Ostial stent

ABSTRACT

An improved medical device for use in the treatment of stenosis of the ostium of tubular organs, such as, but not limited to blood vessels. The improved medical device includes a configuration and design that enables at least one end region of the improved medical device to flare outwardly.

The present invention claims priority on U.S. Provisional ApplicationSer. Nos. 60/627,421 filed Nov. 12, 2004 entitled “Improved OstialStent” and 60/658,289 filed Mar. 3, 2005 entitled “Improved OstialStent”, both of which are incorporated herein by reference.

The invention relates generally to medical devices, and particularly toa medical device for use within a body, and more particularly to amedical device which is useful in repairing various types of bodypassageways, even more particularly to a medical device which is usefulin repairing blood vessels narrowed or occluded by disease, and stilleven more particularly to a medical device in the form of an expandablegraft for the treatment of stenosis at the ostium of tubular organs.

BACKGROUND OF THE INVENTION

Medical treatment of various illnesses or diseases commonly includes theuse of one or more medical devices. Two types of medical devices thatare commonly used to repair various types of body passageways are anexpandable graft or stent, or a surgical graft. These devices have beenimplanted in various areas of the mammalian anatomy.

Old age, dietary habits and primary genetics can also lead to a commondisease, atherosclerosis. Atherosclerotic plaques and blockages consistof lipids, fibroblasts and fibrin that proliferate and cause obstructionof a vessel. As the obstruction grows, the blood flow diminishes andreaches a level that is insufficient to meet the biological needs of oneor more organs. The end result is defined as ischemia.

One purpose of a stent is to open a blocked or partially blocked bodypassageway. When a stent is used in a blood vessel, the stent is used toopen the occluded vessel to achieve improved blood flow which isnecessary to provide for the anatomical function of an organ. Theprocedure of opening a blocked or partially blocked body passagewaycommonly includes the use of one or more stents in combination withother medical devices such as, but not limited to, an introducer sheath,a guiding catheter, a guide wire, an angioplasty balloon, etc.

The use of stents in blood vessels and other structures in the body hasbecome a well established clinical procedure over the past severalyears. The equipment and techniques for deploying stents inside bloodvessels are well established. There are very few dedicated devices ortechniques available for stenting the ostium of blood vessels. Moststents currently available are very difficult to position in the ostiumof arteries; since the stent is either inserted too far leaving acritical portion of a lesion uncovered, or the stent protrudes too farout into a-major blood vessel such as the aorta or the left maincoronary artery. This problem occurs with balloon expandable, as well asself-expanding stents.

Several stents are known to the art. MacGregor, U.S. Pat. No. 4,994,071,discloses a stent having an enlarged end (bifurcation). Maginot, U.S.Pat. No. 5,456,712, discloses a flanged stent member. Mori, U.S. Pat.No. 5,466,242, discloses a shape memory alloy stent where a portion ofthe stent linearly flares in a funnel/conical shape to hold the stent inplace. Lam, U.S. Pat. No. 5,607,444 discloses a specialized ostial stentfor repairing vessels at bifurcations. Yadav, U.S. Pat. No. 6,293,964discloses a specialized ostial stent having a plurality of flat flaringmembers that are used to hold the stent in the ostia. All of theabove-identified stent designs and methodology of use are incorporatedherein by reference.

SUMMARY OF THE INVENTION

The invention relates generally to medical devices, and particularly toa medical device for use within a body, and more particularly to amedical device which is useful in repairing various types of bodypassageways. In one non-limiting embodiment of the invention, theinvention relates to a medical device in the form of an expandable graftwhich is useful in repairing blood vessels or other types of bodypassageways that have been narrowed or occluded by disease. In anotherand/or alternative non-limiting embodiment of the invention, theinvention relates to a medical device in the form of an expandable graftfor the treatment of stenosis at the ostium of tubular organs. In stillanother and/or alternative non-limiting embodiment of the invention, theinvention relates to a medical device in the form of an expandable graftdesigned for introduction into a tubular organ in a body; however, itcan be appreciated that the medical device can be used in other regionsof a body. The medical device can be used in the treatment of stenosisat the ostium of tubular organs and more particularly of blood vessels.The medical device includes an expandable body portion, and a flaringend section that is capable of self flaring and/or being flared. Asdefined herein, the term “body passageway” is defined to be anypassageway or cavity in a living organism (e.g., bile duct, bronchioletubes, nasal cavity, blood vessels, heart, esophagus, trachea, stomach,fallopian tube, uterus, ureter, urethra, the intestines, lymphaticvessels, nasal passageways, eustachian tube, acoustic meatus, etc.). Thetechniques employed to deliver the medical device to a treatment areainclude, but are not limited to, angioplasty, vascular anastomoses,transplantation, implantation, subcutaneous introduction, minimallyinvasive surgical procedures, and any combinations thereof. As can beappreciated, other or additional techniques may be used. For vascularapplications, the term “body passageway” primarily refers to bloodvessels and chambers in the heart. In one non-limiting application ofthe medical device of the present invention, the medical device can bedesigned to treat a stenosis at the ostium of a body passageway. In suchan application, the medical device in the form of an expandable graft isplaced within the body passageway with its flaring section at theostium, the flaring section is caused to flare and/or self-flares, andthe remainder of the body of the expandable graft is expanded or selfexpands. The flaring of the flaring section can be achieved at leastpartially at the same time and/or at least partially at a different timefrom the expansion of the body portion.

In one non-limiting aspect of the invention, the expandable body portionof the medical device is capable of radial expansion, by self-expansionand/or balloon expansion; however, other types of expansion can be used.The expandable body portion of the medical device can include geometricpatterns or structural configurations that facilitate in the radialexpansion of the expandable body portion. The expandable body portion ofthe medical device typically has sufficient radial strength to retainits expanded cross-sectional area after expansion. In one non-limitingdesign, the medical device includes a material having a lowmetal-to-opening ratio. In one non-limiting embodiment of the invention,the medical device can be balloon expandable and/or self-expanding; orexpanded in another manner. In one non-limiting example, aballoon-expandable medical device can be loaded onto a balloon of aballoon dilatation catheter with the flaring section unexpanded andsubstantially parallel to the longitudinal axis of the body of themedical device. The medical device can be placed upon the balloon withthe flaring section on or adjacent to the proximal portion of theballoon and the body loaded on the middle or distal portion of theballoon; however, this is not required. There may be applications wherethis position of the medical device on the balloon is reversed. As canbe appreciated, one or more balloons can be used to at least partiallyexpand the medical device. In one non-limiting specific arrangement, asingle balloon is used to expand one or more regions of the medicaldevice. In another and/or alternative non-limiting specific arrangement,at least two balloons are used to at least partially expand the medicaldevice. Typically the two balloons expand to different shapes and/orsizes. For instance, one balloon can be designed to at least partiallyexpand at least a portion of the body portion, and another balloon canbe designed to at least partially expand at least a portion of theflaring section of the medical device. When one balloon is used, theballoon can be repositioned in the medical device to expand differentregions of the medical device; however, this is not required. In stillanother and/or alternative non-limiting specific arrangement, a balloonthat includes two or more sections can be used to at least partiallyexpand the medical device. For instance, the balloon can be designed tobe divided into at least two sections that expand to different sizesand/or shapes. The medical device is positioned on the balloon such thatdifferent sections of the balloon, when expanded, affect the expansionof the medical device in different ways. For example, one section of theballoon can be designed to at least partially expand at least a portionof the body portion, and another section of the balloon can be designedto at least partially expand at least a portion of the flaring sectionof the medical device. As can be appreciated, many other balloonconfigurations and/or medical device positioning of the balloon can beused to at least partially expand the medical device. As can also beappreciated, the one or more balloons can be used to at least partiallyexpand the medical device at different times (e.g., initially at leastpartially expand the body portion and then at least partially expand theflaring section, etc.). The balloon and medical device can be advancedto a desired site by use of a guiding catheter and a guide wire;however, other positioning mechanisms can be used. After the medicaldevice is positioned at a desired site in the tubular organ, it can bedeployed in a manner to permit the flaring section to flare or expand atthe ostium. The flaring of the flaring section can occur before, duringand/or after the expansion of the non-flaring portion of the medicaldevice in the tubular organ. When the medical device is at leastpartially formed of a spring-like, shape memory, or similar material soas to be at least partially self-expanding, the medical device can besecured to a delivery catheter in an unexpanded state or positioned in adelivery sheath and/or maintained in such shape by another or additionalphysical hindrance and then advanced through a guiding catheter orprotective sheath to a desired location. As can be appreciated, othermechanisms can be used to advance the medical device to a desired sitein a tubular organ. There are a number of known delivery systems fordelivery of a self-expanding medical device. Non-limiting examples ofsuch delivery systems than can be used to delivery the medical device ofthe present invention to a desired site in a tubular organ are disclosedin U.S. Pat. Nos. 4,886,062, 4,913,141, 5,019,085, 5,147,370, 5,372,600,5,507,768, 5,549,635, 5,607,467, 5,632,760, 5,643,278, and 5,669,932,all of which are incorporated herein by reference. Once the medicaldevice is positioned in a desired location, the medical device istypically released from the delivery catheter, sheath or the like.

In another and/or alternative non-limiting aspect of the invention, themedical device can be designed to be in the form of a stent that isconfigured to have at least two sections, an expandable body portionthat has a generally constant diameter in an expanded state, and aflaring section with multiple different diameters when in an expandedstate; however, it can be appreciated that the body portion can have avariable diameter over the length of the body portion. The medicaldevice can be made of a uniform material, or one or more regions of themedical device can be formed of different materials (e.g., metal,polymer, plastic, fiber reinforced material, etc.). Typically the bodyportion and the flaring portion are formed of the same or similarmaterials so as to 1) simplify the manufacturing process associated withthe medical device and/or 2)inhibit or prevent corrosion at the jointbetween two of more different materials. One or more portions of themedical device can be formed of a biostable material and/or anon-biostable material (e.g., biodegradable, bioabsorbable, etc.). Somenon-limiting metals that can be used to at least partially form themedical device include, but are not limited to, aluminum, barium,bismuth, calcium, cobalt, copper, chromium, gold, iron, stainless steel,titanium, vanadium, nickel, zirconium, niobium, lead, molybdenum,platinum, magnesium, yttrium, calcium, rare earth metals, rhenium, zinc,silver, depleted radioactive elements, tantalum, tungsten and/or alloysthereof (e.g., nitinol, etc.). In one non-limiting example, one or moreportions of the expandable body portion and/or flaring sections can befabricated from material that 1) has no or substantially no shape memorycharacteristics (e.g., stainless steel, cobalt, chromium, magnesium,rhenium, zinc, titanium, tantalum, zirconium, etc.), and/or 2) hasshape-memory characteristics (e.g., nickel-titanium alloy (nitinol), oranother metallic or non-metallic material which possesses thecharacteristic of shape memory). The sections of the medical device canhave a uniform architectural configuration, or can have differingarchitectural configurations. Each of the sections of the medical devicecan be formed of a single part or formed of multiple parts which havebeen attached together. When a section of the medical device is formedof multiple parts, typically the section is formed into one continuouspiece; however, this is not required. In another and/or alternativenon-limiting example, one or more portions of the medical device caninclude a bistable construction. In such a design, the medical devicehas two or more stable configurations, including a first stableconfiguration with a first cross-sectional shape and a second stableconfiguration with a second cross-sectional shape. All or a portion ofthe medical device can include the bistable construction. The bistableconstruction can result in a generally uniform change in shape of themedical device, or one portion of the medical device can change into oneor more configurations and one or more other portions of the medicaldevice can change into one or more other configurations.

In still another and/or alternative non-limiting aspect of theinvention, the expandable body portion of the medical device generallyconstitutes a larger portion of the longitudinal length of the medicaldevice; however, this is not required. The flaring section of themedical device in an expanded state has multiple different diametersresulting in an outward flare of the flaring section with respect to thelongitudinal axis of the medical device. This outward flare results inthe end of the flaring section typically having the largest diameter ofthe medical device when the flaring section has been expanded. In onenon-limiting embodiment, the flaring section constitutes less than amajority of the longitudinal length of the medical device and theexpandable body portion constitutes a majority of the longitudinallength of the medical device. In one non-limiting aspect of thisembodiment, the flaring section constitutes up to about 40 percent ofthe longitudinal length of the medical device and the expandable bodyportion constitutes at least about 60 percent of the longitudinal lengthof the medical device. In another and/or alternative non-limiting aspectof this embodiment, the flaring section constitutes up to about 25percent of the longitudinal length of the medical device and theexpandable body portion constitutes at least about 75 percent of thelongitudinal length of the medical device. In still another and/oralternative non-limiting aspect of this embodiment, the flaring sectionconstitutes up to about 20 percent of the longitudinal length of themedical device and the expandable body portion constitutes at leastabout 80 percent of the longitudinal length of the medical device. Inyet another and/or alternative non-limiting aspect of this embodiment,the flaring section constitutes up to about 15 percent of thelongitudinal length of the medical device and the expandable bodyportion constitutes at least about 85 percent of the longitudinal lengthof the medical device. As can be appreciated, other length ratios of theflaring section and expandable body portion can be used. In onenon-limiting design of the medical device for use in a blood vessel, theexpandable body portion is about 5-20 mm and the flaring section isabout 0.5-4 mm. In another and/or alternative non-limiting design of themedical device for use in a blood vessel, the expandable body portion isabout 7-18 mm and the flaring section is about 1-3 mm. In still anotherand/or alternative non-limiting design of the medical device for use ina blood vessel, the expandable body portion is about 8-16 mm and theflaring section is about 1-2 mm. As can be appreciated, other length ofthe flaring section and expandable body portion of the medical devicecan be used. In still another and/or alternative non-limiting embodimentof the invention, the flaring portion of the medical device is designedto have a maximum expanded diameter of about 5-14 mm, typically about7-12 mm, and more typically about 9-11 mm. This maximum diameter of theflaring section enables the medical device to be positioned in a varietyof vascular passageways and to provide substantially complete coverageof the region about the ostium. In yet another and/or alternativenon-limiting embodiment of the invention, the maximum diameter of theexpanded flaring section of the medical device is at least about 25%greater than the maximum diameter of the expanded body portion. In stillanother and/or alternative non-limiting embodiment, the flaring section,in an expanded state, is large enough in size to cover the area aboutthe ostium. In some prior art designs, the flaring section of the stentwas not large enough to cover at least a portion of the body passagewaysurrounding the ostium. One such stent is disclosed in US 2003/0083734published May 1, 2003, which is incorporated herein by reference. Asshown in FIG. 3, the edge of the flaring section of the stent ispositioned flushed with the blood vessel about the ostium. As such, theflaring section does not overlay any portion of the blood vessel aboutthe ostium. The medical device of the present invention is designed tohave a flaring section sized so that at least 0.25 mm of the bloodvessel about the complete ostium is covered by the flaring section whenthe flaring section is expanded. This novel configuration better securesthe medical device in the body passageway and/or can reduce theincidence of restenosis. In one non-limiting design, the medical deviceof the present invention is designed to have a flaring section sized sothat about 0.25-5 mm of the blood vessel about the complete ostium iscovered by the flaring section when the flaring section is expanded. Instill another non-limiting design, the medical device of the presentinvention is designed to have a flaring section sized so that about0.5-4 mm of the blood vessel about the complete ostium is covered by theflaring section when the flaring section is expanded. As can beappreciated, the medical device of the present invention can be designedto have a flaring section sized so that other amounts of the bloodvessel about the complete ostium can be covered by the flaring sectionwhen the flaring section is expanded. In still another and/oralternative non-limiting embodiment, the flaring section, in an expandedstate, has a generally nonlinear rate of flaring over the completelongitudinal length of the flaring section; however, it can beappreciated that the rate of flaring can be linear. In one non-limitingaspect of this embodiment, the rate of nonlinear flaring of the flaringsection in the expanded state relative to the longitudinal axis of themedical device is a generally second order rate of curvature. In anotherand/or alternative non-limiting aspect of this embodiment, the rate ofnonlinear flaring of the flaring section in the expanded state relativeto the longitudinal axis of the medical device is a generally anexponential rate of curvature. In another and/or alternativenon-limiting aspect of this embodiment, the rate of nonlinear flaring ofthe-flaring section in the expanded state relative to the longitudinalaxis of the medical device is a plurality of linear flaring rates overthe longitudinal length of the flaring section. As can be appreciated,other rates of nonlinear flaring can be used. In still another and/oralternative non-limiting aspect of this embodiment, the maximum angle offlaring of the flaring section, in an expanded state, relative to thelongitudinal axis of the medical device is up to about 160°. In yetanother and/or alternative non-limiting aspect of this embodiment, themaximum angle of flaring of the flaring section, in an expanded state,relative to the longitudinal axis of the medical device is up to about130°. In still yet another and/or alternative non-limiting aspect ofthis embodiment, the maximum angle of flaring of the flaring section, inan expanded state, relative to the longitudinal axis of the medicaldevice is up to about 120°. As can be appreciated, other maximum anglesof flaring of the flaring section can be used. The flaring section, inthe expanded state, can have one portion that has a greater maximumangle of flaring than another portion. Such non-uniform expansion of theflaring section can result in part from geometry of the body passagewayin which the medical device expands. Typically the body passageways onthe body do not branch off another body passageway at a 90° angle.Indeed, it is common for a branched tubular organ or vessel to intersectanother tubular organ or vessel at an angle other than 90°. As such, theproper coverage of the ostium can be difficult, if not impossible, whenusing a standard expandable stent. Stent designs that had a flare angleof 90° or less could not fully cover the region about the ostium afterthe flaring section has been fully expanded. As such, this uncoveredregion about the ostium can result in vasculature ingrowth, whichingrowth may result in an increased incidence of restenosis. Inaddition, the inability of the complete edge of the flaring section tocover and contact the region about the ostium is believed to increasethe incidence of 1) clotting and/or deposits forming between the flaringsection and the surface about the ostium, and/or 2) interference withother medical devices being inserted in and/or moved past the regionabout ostium. The novel design of the flaring section of the medicaldevice of the present invention overcomes all of the past limitationsthat were associated with prior ostial designs. The ability of theflaring section to expand at an angle greater than 90° relative to thelongitudinal axis of the medical device is a significant improvementover prior stents that had a maximum flare angle of 90° or less (See US2003/0083734; US 2004/0093058; US 2005/0049678; WO 2005/046526). Assuch, when a treated body passageway branches off another bodypassageway at an angle other than 90°, the maximum flare angle of theflaring section of the medical device of the present invention in theexpanded state will be less than 90° about one portion about the ostiumand greater than 90° about another portion of the ostium. As a result,the flaring section of the medical device of the present inventionprovides significantly better coverage of the ostium, thus is believedto better facilitate in the inhibition or prevention of restenosis. Theflaring section of the medical device of the present invention alsoenables the flaring section to better and more closely conform to theostium of the tubular organ, thereby facilitating in firmly securing themedical device at such site. Radial expansion of the body enables themedical device to substantially conform to, and press against, the innerwall and stenosis of a tubular organ or vessel, thereby seating themedical device. The expansion of the flaring section enables the flaringsection to fully cover the ostium of the tubular organ. In a furtherand/or alternative embodiment of the invention, the flaring section andthe body portion of the medical device do not have any discontinuitiesbetween the body portion and flaring section. Some prior ostial stentsincluded an expanded structural configuration of the body portion thatwas secured to one or more ends of the stent by a one or moreconnectors. For instance, the stent design disclosed in Mori, US Pat.No. 5,466,242 includes a transition portion between the body of thestent and one end of the stent, thus forming a non-uniform structuraltransition between the body and end section of the stent. This type ofnon-uniform transition can compromise the strength and/or effectivenessof the stent. In other stent designs, one or more ends of the stent didnot maintain a uniform structure. Two such stents are disclosed in US2004/0254627 and US 2005/0154447. These two stents include an endportion that has a plurality of flat flaring members. These flaringmembers separate from one another; thereby creating a non-uniform endportion in-the expanded state. This non-uniform end portion whenexpanded in a vascular passageway can allow for tissue growth betweenthe flat flaring members, which tissue growth is believed to potentiallyincrease the incidence of restenosis. The medical device of the presentinvention is designed to overcome both of these past limitationsregarding prior stents. The body portion and flaring section of themedical device have a uniform structure. In one non-limitingconfiguration, the flaring section, in an expanded state, maintains asubstantially single and uniform structure. Due to this configuration,tissue growth under the expanded flaring section is substantiallyinhibited, thereby is believed to facilitate in the inhibition orprevention of restenosis. Typically, at least about 90% of the flaringsection, in an expanded state, maintains a substantially single anduniform structure, and more typically at least about 95% of the flaringsection, in an expanded state, maintains a substantially single anduniform structure, and even more typically at least about 98% of theflaring section, in an expanded state, maintains a substantially singleand uniform structure.

In yet another and/or alternative non-limiting aspect of the invention,the medical device can be fully or partially formed of a base materialthat has biostable or bioabsorbable properties. The medical device canbe at least partially formed of one or more polymers, biological agents,metals (e.g., aluminum, barium, bismuth, calcium, cobalt, copper,chromium, depleted radioactive elements, gold, iron, lead, molybdenum,magnesium, nickel, niobium, platinum, rare earth metals, rhenium,silver, tantalum, titanium, tungsten, vanadium, yttrium, zinc,zirconium, and/or alloys thereof (e.g., stainless steel, nitinol, Cr—Co,Mo—Re, Ta—W, Mg—Zr, Mg—Zn, etc.)), ceramics, and/or fiber reinforcedmaterials (e.g., carbon fiber material, fiberglass, etc.). As can beappreciated; other or additional materials can be used. The medicaldevice generally includes one or more materials that impart the desiredproperties to the medical device so as to withstand the manufacturingprocess that is needed to produce the medical device. Thesemanufacturing processes can include, but are not limited to, lasercutting, etching, grinding, water cutting, spark erosion, crimping,annealing, drawing, pilgering, electroplating, electro-polishing,chemical polishing, ion beam deposition or implantation, sputtercoating, vacuum deposition, etc.

In still yet another and/or alternative non-limiting aspect of thepresent invention, the medical device can include and/or be used with aphysical hindrance. The physical hindrance can include, but is notlimited to, an adhesive, a sheath, a magnet, tape, wire, string, etc.The physical hindrance can be used to 1) physically retain one or moreregions of the medical device in a particular form or profile, 2)physically retain the medical device on a particular deployment device,3) protect one or more surface structures and/or micro-structures on themedical device, and/or 4) form a barrier between one or more surfaceregions, surface structures and/or micro-structures on the medicaldevice and the fluids in a body passageway. As can be appreciated, thephysical hindrance can have other and/or additional functions. Thephysical hindrance can be a biodegradable material; however, a biostablecan also or alternatively be used. The physical hindrance can bedesigned to withstand sterilization of the medical device; however, thisis not required. The physical hindrance can be applied to, included inand/or be used in conjunction with one or more medical devices; however,this is not required. Additionally or alternatively, the physicalhindrance can be designed to be used with and/or conjunction with amedical device for a limited period of time and then 1) disengage fromthe medical device after the medical device has been partially or fullydeployed and/or 2) dissolve and/or degrade during and/or after themedical device has been partially or fully deployed; however, this isnot required. Additionally or alternatively, the physical hindrance canbe designed and/or be formulated to be temporarily used with a medicaldevice to facilitate in the deployment of the medical device; however,this is not required. In one non-limiting use of the physical hindrance,the physical hindrance is designed and/or formulated to at leastpartially secure the medical device to another device that is used to atleast partially transport the medical device to a location fortreatment. In another and/or alternative non-limiting use of thephysical hindrance, the physical hindrance is designed and/or formulatedto at least partially maintain the medical device in a particular shapeor form until the medical device is at least partially positioned in atreatment location. In still another and/or alternative non-limiting useof the physical hindrance, the physical hindrance is designed and/orformulated to at least partially maintain and/or secure the medicaldevice to a medical instrument or other type of device until the medicaldevice is at least partially positioned in a treatment location. Thephysical hindrance can also or alternatively be designed and/orformulated to be used with the medical device to facilitate in the useof the medical device. In one non-limiting use of the physicalhindrance, the physical hindrance is designed and/or formulated to atleast partially secure a medical device to a treatment area so as tofacilitate in maintaining the medical device at the treatment area. Forinstance, the physical hindrance can be used in such use to facilitatein maintaining a medical device on or at a treatment area until themedical device is properly secured to the treatment area by sutures,stitches, screws, nails, rod, etc. Additionally or alternatively, thephysical hindrance can be used to facilitate in maintaining a medicaldevice on or at a treatment area until the medical device has a)partially or fully been expanded and/orb) partially or fullyaccomplished its objective. The physical hindrance can be abiocompatible material so as to not cause unanticipated adverse effectswhen properly used. The physical hindrance can be biostable orbiodegradable (e.g., degrades and/or is absorbed, etc.). When thephysical hindrance includes or is primarily formed of one or moreadhesives, the one or more adhesive can be applied to the medical deviceby, but not limited to, spraying (e.g., atomizing spray techniques,etc.), dip coating, roll coating, sonication, brushing, plasmadeposition, and/or depositing by vapor deposition, brushing, painting,etc.) on the medical device. The physical hindrance can also oralternatively form at least a part of the medical device. One or moreregions and/or surfaces of a medical device can also or alternativelyinclude the physical hindrance. The physical hindrance can include oneor more biological agents and/or other materials (e.g., marker material,polymer, etc.); however, this is not required. When the physicalhindrance is or includes an adhesive, the adhesive can be formulated tocontrollably release one or more biological agents a) included in theadhesive, b) coated on the medical device and/or adhesive, and/or c)contained within the medical device; however, this is not required. Theadhesive can also or alternatively control the release of one or morebiological agents located on and/or contained in the medical device byforming a penetrable or non-penetrable barrier to such biologicalagents; however, this is not required. The adhesive can include and/orbe mixed with one or more polymers; however, this is not required. Theone or more polymers, when used, can be used to 1) control the time ofadhesion provided by said adhesive, 2) control the rate of degradationof the adhesive, and/or 3) control the rate of release of one or morebiological agents released from the adhesive and/or diff-using orpenetrating through the adhesive layer; however, this is not required.When the physical hindrance includes a sheath, the sheath can bedesigned to partially or fully encircle the medical device. The sheathcan be designed to be physically removed from the medical device afterthe medical device is deployed to a treatment area; however, this is notrequired. The sheath can be at least partially formed of a biostablematerial. The sheath can be at least partially formed of a biodegradablematerial that at least partially degrades over time to at leastpartially expose one or more surface regions, micro-structures and/orsurface structures of the medical device; however, this is not required.The sheath can include and/or be at least partially coated with one ormore biological agents; however, this is not required. The sheath caninclude one or more polymers; however, this is not required. The one ormore polymers, when used, can be used for a variety of reasons such as,but not limit ed to, 1) forming a portion of the sheath, 2) improving aphysical property of the sheath (e.g., improve strength, improvedurability, improve biocapatability, reduce friction, etc.), and/or 3)at least partially controlling a release rate of one or more biologicalagents from the sheath. As can be appreciated, the one or more polymers,when used, can have other or additional uses. In one non-limitingexample, the medical device that is in the form of an expandable graftcan be deployed in its final destination by an expansion device (e.g.,balloon, etc.) and/or by use of a shape memory material. As can beappreciated, medical devices that include heat sensitive and/or shapememory materials can be at least partially expanded by a balloon and/oranother type of expansion device. The removal, degradation and/orelimination of the physical hindrance from the medical device enablesthe medical device to at least partially assume its expanded state. Whenthe physical hindrance includes an adhesive and the medical device is atleast partially expanded-by a balloon and/or another type of expansiondevice, the balloon and/or another type of expansion device can beexpanded to at least partially cause the adhesive to break, weaken,etc.; thereby enabling the medical device to at least partially expand;however, this is not required.

In a further and/or alternative non-limiting aspect of the presentinvention, one or more biological agents are used with the medicaldevice to facilitate in the success of the medical device and/or treatedarea. The term “biological agent” includes, but is not limited to, asubstance, drug or otherwise formulated and/or designed to prevent,inhibit and/or treat one or more biological problems, and/or to promotethe healing in a treated area. Non-limiting examples of biologicalproblems that can be addressed by one or more biological agents include,but are not limited to, viral, fungus and/or bacteria infection;vascular diseases and/or disorders; digestive diseases and/or disorders;reproductive diseases and/or disorders; lymphatic diseases and/ordisorders; cancer; implant rejection; pain; nausea; swelling; arthritis;bone diseases and/or disorders; organ failure; immunity diseases and/ordisorders; cholesterol problems; blood diseases and/or disorders; lungdiseases and/or disorders; heart diseases and/or disorders; braindiseases and/or disorders; neuralgia diseases and/or disorders; kidneydiseases and/or disorders; ulcers; liver diseases and/or disorders;intestinal diseases and/or disorders; gallbladder diseases and/ordisorders; pancreatic diseases and/or disorders; psychologicaldisorders; respiratory diseases and/or disorders; gland diseases and/ordisorders; skin diseases and/or disorders; hearing diseases and/ordisorders; oral diseases and/or disorders; nasal diseases and/ordisorders; eye diseases and/or disorders; fatigue; genetic diseasesand/or disorders; burns; scaring and/or scars; trauma; weight diseasesand/or disorders; addiction diseases and/or disorders; hair loss;cramps; muscle spasms; tissue repair; and/or the like. Non-limitingexamples of biological agents that can be used include, but are notlimited to, 5-Fluorouracil and/or derivatives thereof;5-Phenylmethimazole and/or derivatives thereof; ACE inhibitors and/orderivatives thereof; acenocoumarol and/or derivatives thereof; acyclovirand/or derivatives thereof; actilyse and/or derivatives thereof;adrenocorticotropic hormone and/or derivatives thereof; adriamycinand/or derivatives thereof; agents that modulate intracellular Ca₂₊transport such as L-type (e.g., diltiazem, nifedipine, verapamil, etc.)or T-type Ca₂₊ channel blockers (e.g., amiloride, etc.);alpha-adrenergic blocking agents and/or derivatives thereof; alteplaseand/or derivatives thereof; amino glycosides and/or derivatives thereof(e.g., gentamycin, tobramycin, etc.); angiopeptin and/or derivativesthereof; angiostatic steroid and/or derivatives thereof; angiotensin IIreceptor antagonists and/or derivatives thereof; anistreplase and/orderivatives thereof; antagonists of vascular epithelial growth factorand/or derivatives thereof; anti-biotics; anti-coagulant compoundsand/or derivatives thereof; anti-fibrosis compounds and/or derivativesthereof; anti-fungal compounds and/or derivatives thereof;anti-inflammatory compounds and/or derivatives thereof; Anti-InvasiveFactor and/or derivatives thereof; anti-metabolite compounds and/orderivatives thereof (e.g., staurosporin, trichothecenes, and modifieddiphtheria and ricin toxins, Pseudomonas exotoxin, etc.); anti-matrixcompounds and/or derivatives thereof (e.g., colchicine, tamoxifen,etc.); anti-microbial agents and/or derivatives thereof; anti-migratoryagents and/or derivatives thereof (e.g., caffeic acid derivatives,nilvadipine, etc.); anti-mitotic compounds and/or derivatives thereof;anti-neoplastic compounds and/or derivatives thereof; anti-oxidantsand/or derivatives thereof; anti-platelet compounds and/or derivativesthereof; anti-proliferative and/or derivatives thereof;anti-thrombogenic agents and/or derivatives thereof; argatroban and/orderivatives thereof; ap-1 inhibitors and/or derivatives thereof (e.g.,for tyrosine kinase, protein kinase C, myosin light chain kinase,Ca₂₊/calmodulin kinase II, casein kinase II, etc.); aspirin and/orderivatives thereof; azathioprine and/or derivatives thereof;β-Estradiol and/or derivatives thereof; β-1-anticollagenase and/orderivatives thereof; calcium channel blockers and/or derivativesthereof; calmodulin antagonists and/or derivatives thereof (e.g., H₇,etc.) ; CAPTOPRIL and/or derivatives thereof; cartilage-derivedinhibitor and/or derivatives thereof; ChIMP-3 and/or derivativesthereof; cephalosporin and/or derivatives thereof (e.g., cefadroxil,cefazolin, cefaclor, etc.); chloroquine and/or derivatives thereof;chemotherapeutic compounds and/or derivatives thereof (e.g.,5-fluorouracil, vincristine, vinblastine, cisplatin, doxyrubicin,adriamycin, tamocifen, etc.); chymostatin and/or derivatives thereof;CILAZAPRIL and/or derivatives thereof; clopidigrel and/or derivativesthereof; clotrimazole and/or derivatives thereof; colchicine and/orderivatives thereof; cortisone and/or derivatives thereof; coumadinand/or derivatives thereof; curacin-A and/or derivatives thereof;cyclosporine and/or derivatives thereof; cytochalasin and/or derivativesthereof (e.g., cytochalasin A, cytochalasin B, cytochalasin C,cytochalasin D, cytochalasin E, cytochalasin F, cytochalasin G,cytochalasin H, cytochalasin J, cytochalasin K, cytochalasin L,cytochalasin M, cytochalasin N, cytochalasin O, cytochalasin P,cytochalasin Q, cytochalasin R, cytochalasin S, chaetoglobosin A,chaetoglobosin B, chaetoglobosin C, chaetoglobosin D, chaetoglobosin E,chaetoglobosin F, chaetoglobosin G, chaetoglobosin J, chaetoglobosin K,deoxaphomin, proxiphomin, protophomin, zygosporin D, zygosporin E,zygosporin F, zygosporin G, aspochalasin B, aspochalasin C, aspochalasinD, etc.); cytokines and/or derivatives thereof; desirudin and/orderivatives thereof; dexamethazone and/or derivatives thereof;dipyridamole and/or derivatives thereof; eminase and/or derivativesthereof; endothelin and/or derivatives thereof; endothelial growthfactor and/or derivatives thereof; epidermal growth factor and/orderivatives thereof; epothilone and/or derivatives thereof; estramustineand/or derivatives thereof; estrogen and/or derivatives thereof;fenoprofen and/or derivatives thereof; fluorouracil and/or derivativesthereof; flucytosine and/or derivatives thereof; forskolin and/orderivatives thereof; ganciclovir and/or derivatives thereof;glucocorticoids and/or derivatives thereof (e.g., dexamethasone,betamethasone, etc.); glycoprotein IIb/IIIa platelet membrane receptorantibody and/or derivatives thereof; GM-CSF and/or derivatives thereof;griseofulvin and/or derivatives thereof; growth factors and/orderivatives thereof (e.g., VEGF; TGF; IGF; PDGF; FGF, etc.); growthhormone and/or derivatives thereof; heparin and/or derivatives thereof;hirudin and/or derivatives thereof; hyaluronate and/or derivativesthereof; hydrocortisone and/or derivatives thereof; ibuprofen and/orderivatives thereof; immunosuppressive agents and/or derivatives thereof(e.g., adrenocorticosteroids, cyclosporine, etc.); indomethacin and/orderivatives thereof; inhibitors of the sodium/calcium antiporter and/orderivatives thereof (e.g., amiloride, etc.); inhibitors of the IP₃receptor and/or derivatives thereof; inhibitors of the sodium/hydrogenantiporter and/or derivatives thereof (e.g., amiloride and derivativesthereof, etc.); insulin and/or derivatives thereof; Interferon alpha 2Macroglobulin and/or derivatives thereof; ketoconazole and/orderivatives thereof; Lepirudin and/or derivatives thereof; LISINOPRILand/or derivatives thereof; LOVASTATIN and/or derivatives thereof;marevan and/or derivatives thereof; mefloquine and/or derivativesthereof; metalloproteinase inhibitors and/or derivatives thereof;methotrexate and/or derivatives thereof; metronidazole and/orderivatives thereof; miconazole and/or derivatives thereof; monoclonalantibodies and/or derivatives thereof; mutamycin and/or derivativesthereof; naproxen and/or derivatives thereof; nitric oxide and/orderivatives thereof; nitroprusside and/or derivatives thereof; nucleicacid analogues and/or derivatives thereof (e.g., peptide nucleic acids,etc.); nystatin and/or derivatives thereof; oligonucleotides and/orderivatives thereof; paclitaxel and/or derivatives thereof; penicillinand/or derivatives thereof; pentamidine isethionate and/or derivativesthereof; phenindione and/or derivatives thereof; phenylbutazone and/orderivatives thereof; phosphodiesterase inhibitors and/or derivativesthereof; Plasminogen Activator Inhibitor-1 and/or derivatives thereof;Plasminogen Activator Inhibitor-2 and/or derivatives thereof; PlateletFactor 4 and/or derivatives thereof; platelet derived growth factorand/or derivatives thereof; plavix and/or derivatives thereof; POSTMI 75and/or derivatives thereof; prednisone and/or derivatives thereof;prednisolone and/or derivatives thereof; probucol and/or derivativesthereof; progesterone and/or derivatives thereof; prostacyclin and/orderivatives thereof; prostaglandin inhibitors and/or derivativesthereof; protamine and/or derivatives thereof; protease and/orderivatives thereof; protein kinase inhibitors and/or derivativesthereof (e.g., staurosporin, etc.); quinine and/or derivatives thereof;radioactive agents and/or derivatives thereof(e.g., Cu-64, Ca-67,Cs-131, Ga-68, Zr-89, Ku-97, Tc-99m, Rh-105, Pd-103, Pd-109, In-111,I-123, I-125, I-131, Re-186, Re-188, Au-198, Au-199, Pb-203, At-211,Pb-212, Bi-212, H₃P³²O₄, etc.); rapamycin and/or derivatives thereof;receptor antagonists for histamine and/or derivatives thereof; refludanand/or derivatives thereof; retinoic acids and/or derivatives thereof;revasc and/or derivatives thereof; rifamycin and/or derivatives thereof;sense or anti-sense oligonucleotides and/or derivatives thereof (e.g.,DNA, RNA, plasmid DNA, plasmid RNA, etc.); seramin and/or derivativesthereof; steroids; seramin and/or derivatives thereof; serotonin and/orderivatives thereof; serotonin blockers and/or derivatives thereof;streptokinase and/or derivatives thereof; sulfasalazine and/orderivatives thereof; sulfonamides and/or derivatives thereof (e.g.,sulfamethoxazole, etc.); sulphated chitin derivatives; SulphatedPolysaccharide Peptidoglycan Complex and/or derivatives thereof; T_(H1)and/or derivatives thereof(e.g., Interleukins-2, -12, and -15, gammainterferon, etc.); thioprotese inhibitors and/or derivatives thereof;taxol and/or derivatives thereof (e.g., taxotere, baccatin,10-deacetyltaxol, 7-xylosyl-10-deacetyltaxol, cephalomannine,10-deacetyl-7-epitaxol, 7 epitaxol, 10-deacetylbaccatin III,10-deacetylcephaolmannine, etc.); ticlid and/or derivatives thereof;ticlopidine and/or derivatives thereof; tick anti-coagulant peptideand/or derivatives thereof; thioprotese inhibitors and/or derivativesthereof; thyroid hormone and/or derivatives thereof; Tissue Inhibitor ofMetalloproteinase-1 and/or derivatives thereof; Tissue Inhibitor ofMetalloproteinase-2 and/or derivatives thereof; tissue plasmaactivators; TNF and/or derivatives thereof, tocopherol and/orderivatives thereof; toxins and/or derivatives thereof; tranilast and/orderivatives thereof; transforming growth factors alpha and beta and/orderivatives thereof; trapidil and/or derivatives thereof;triazolopyrimidine and/or derivatives thereof; vapiprost and/orderivatives thereof; vinblastine and/or derivatives thereof; vincristineand/or derivatives thereof; zidovudine and/or derivatives thereof As canbe appreciated, the biological agent can include one or more derivativesof the above listed compounds and/or other compounds. In onenon-limiting embodiment, the biological agent includes, but is notlimited to, trapidil, trapidil derivatives, taxol, taxol derivatives,cytochalasin, cytochalasin derivatives, paclitaxel, paclitaxelderivatives, rapamycin, rapamycin derivatives, 5-Phenylmethimazole,5-Phenylmethimazole derivatives, GM—CSF, GM-CSF derivatives, orcombinations thereof The type and/or amount of biological agent includedon, in and/or in conjunction with the medical device is generallyselected for the treatment of one or more medical treatments. Typicallythe amount of biological agent included on, in and/or used inconjunction with the medical device is about 0.01-100 ug per mm²;however, other amounts can be used. The amount of two of more biologicalagents on, in and/or used in conjunction with the medical device can bethe same or different. In one non-limiting example, the medical devicecan be coated with and/or includes one or more biological agents suchas, but not limited to, trapidil and/or trapidil derivatives, taxol,taxol derivatives (e.g., taxotere, baccatin, 10-deacetyltaxol,7-xylosyl-10-deacetyltaxol, cephalomannine, 10-deacetyl-7-epitaxol, 7epitaxol, 10-deacetylbaccatin III, 10-deacetylcephaolmannine, etc.),cytochalasin, cytochalasin derivatives (e.g., cytochalasin A,cytochalasin B, cytochalasin C, cytochalasin D, cytochalasin E,cytochalasin F, cytochalasin G, cytochalasin H, cytochalasin J,cytochalasin K, cytochalasin L, cytochalasin M, cytochalasin N,cytochalasin O, cytochalasin P, cytochalasin Q, cytochalasin R,cytochalasin S, chaetoglobosin A, chaetoglobosin B, chaetoglobosin C,chaetoglobosin D, chaetoglobosin E, chaetoglobosin F, chaetoglobosin G,chaetoglobosin J, chaetoglobosin K, deoxaphomin, proxiphomin,protophomin, zygosporin D, zygosporin E, zygosporin F, zygosporin G,aspochalasin B, aspochalasin C, aspochalasin D, etc.), paclitaxel,paclitaxel derivatives, rapamycin, rapamycin derivatives,5-Phenylmethimazole, 5-Phenylmethimazole derivatives, GM-CSF(granulo-cyte-macrophage colony-stimulating-factor), GM-CSF derivatives,or combinations thereof. In one non-limiting embodiment of theinvention, the medical device can be partially of fully coated with oneor more biological agents to facilitate in the success of a particularmedical procedure. The one or more biological agents can be coated onthe medical device by a variety of mechanisms such as, but not limitedto, spraying (e.g., atomizing spray techniques, etc.), dip coating, rollcoating, sonication, brushing, plasma deposition, depositing by vapordeposition. In another and/or alternative non-limiting embodiment of theinvention, the type and/or amount of biological agent included on, inand/or in conjunction with the medical device is generally selected forthe treatment of one or more medical treatments. Typically the amount ofbiological agent included on, in and/or used in conjunction with themedical device is about 0.01-100 ug per mm²; however, other amounts canbe used. The amount of two of more biological agents on, in and/or usedin conjunction with the medical device can be the same or different. Forinstance, one or more biological agents can be coated on, and/orincorporated in one or more portions of the medical device to providelocal and/or systemic delivery of one or more biological agents inand/or to a body passageway to a) inhibit or prevent thrombosis,in-stent restenosis, vascular narrowing and/or restenosis after themedical device has been inserted in and/or connected to a bodypassageway, b) at least partially passivate, remove and/or dissolvelipids, fibroblast, fibrin, etc. in a body passageway so as to at leastpartially remove such materials and/or to passivate such vulnerablematerials (e.g., vulnerable plaque, etc.) in the body passageway in theregion of the medical device and/or down stream of the medical device.As can be appreciated, the one or more biological agents can have manyother or additional uses. In another non-limiting example, the medicaldevice is coated with and/or includes one or more biological agents suchas, but not limited to, trapidil and/or trapidil derivatives, taxol,taxol derivatives, cytochalasin, cytochalasin derivatives, paclitaxel,paclitaxel derivatives, rapamycin, rapamycin derivatives,5-Phenylmethimazole, 5-Phenylmethimazole derivatives, GM-CSF, GM-CSFderivatives, or combinations thereof. In still another non-limitingexample, the medical device is coated with and/or includes one or morebiological agents such as, but not limited trapidil, trapidilderivatives, taxol, taxol derivatives, cytochalasin, cytochalasinderivatives, paclitaxel, paclitaxel derivatives, rapamycin, rapamycinderivatives, 5-Phenylmethimazole, 5-Phenylmethimazole derivatives,GM-CSF, GM-CSF derivatives, or combinations thereof, and one or moreadditional biological agents, such as, but not limited to, biologicalagents associated with thrombolytics, vasodilators, anti-hypertensiveagents, anti-microbial or anti-biotic, anti-mitotic, anti-proliferative,anti-secretory agents, non-steroidal anti-inflammatory drugs,immunosuppressive agents, growth factors and growth factor antagonists,antitumor and/or chemotherapeutic agents, anti-polymerases, anti-viralagents, anti-body targeted therapy agents, hormones, anti-oxidants,biologic components, radio-therapeutic agents, radiopaque agents and/orradio-labeled agents.

In a further and/or alternative non-limiting aspect of the presentinvention, the one or more biological agents on and/or in the medicaldevice, when used on the medical device, can be released in a controlledmanner so the area in question to be treated is provided with thedesired dosage of biological agent over a sustained period of time. Ascan be appreciated, controlled release of one or more biological agentson the medical device is not always required and/or desirable. As such,one or more of the biological agents on and/or in the medical device canbe uncontrollably released from the medical device during and/or afterinsertion of the medical device in the treatment area. It can also beappreciated that one or more biological agents on and/or in the medicaldevice can be controllably released from the medical device and one ormore biological agents on and/or in the medical device can beuncontrollably released from the medical device. It can also beappreciated that one or more biological agents on and/or in one regionof the medical device can be controllably released from the medicaldevice and one or more biological agents on and/or in the medical devicecan be uncontrollably released from another region on the medicaldevice. As such, the medical device can be designed such that 1) all thebiological agent on and/or in the medical device is controllablyreleased, 2) some of the biological agent on and/or in the medicaldevice is controllably released and some of the biological agent on themedical device is non-controllably released, or 3) none of thebiological agent on and/or in the medical device is controllablyreleased. The medical device can also be designed such that the rate ofrelease of the one or more biological agents from the medical device isthe same or different. The medical device can also be designed such thatthe rate of release of the one or more biological agents from one ormore regions on the medical device is the same or different.Non-limiting arrangements that can be used to control the release of oneor more biological agent from the medical device include a) at leastpartially coat one or more biological agents with one or more polymers,b) at least partially incorporate and/or at least partially encapsulateone or more biological agents into and/or with one or more polymers,and/or c) insert one or more biological agents in pores, passageway,cavities, etc. in the medical device and at least partially coat orcover such pores, passageway, cavities, etc. with one or more polymers.As can be appreciated, other or additional arrangements can be used tocontrol the release of one or more biological agent from the medicaldevice. The one or more polymers used to at least partially control therelease of one or more biological agent from the medical device can beporous or non-porous. The one or more biological agents can be insertedinto and/or applied to one or more surface structures and/ormicro-structures on the medical device, and/or be used to at leastpartially form one or more surface structures and/or micro-structures onthe medical device. As such, the one or more biological agents on themedical device can be 1) coated on one or more surface regions of themedical device, 2) inserted and/or impregnated in one or more surfacestructures and/or micro-structures, etc. of the medical device, and/or3) form at least a portion or be included in at least a portion of thestructure of the medical device. When the one or more biological agentsare coated on the medical device, the one or more biological agentscan 1) be directly coated on one or more surfaces of the medical device,2) be mixed with one or more coating polymers or other coating materialsand then at least partially coated on one or more surfaces of themedical device, 3) be at least partially coated on the surface ofanother coating material that has been at least partially coated on themedical device, and/or 4) be at least partially encapsulated between a)a surface or region of the medical device and one or more other coatingmaterials and/or b) two or more other coating materials. As can beappreciated, many other coating arrangements can be additionally oralternatively used. When the one or more biological agents are insertedand/or impregnated in one or more surface structures and/ormicro-structures of the medical device, 1) one or more other coatingmaterials can be applied at least partially over the one or more surfacestructures and/or micro-structures of the medical device, and/or 2) oneor more polymers can be combined with one or more biological agents. Ascan be appreciated, many other and/or additional coating combinationsand/or configurations can be used. The concentration of one or morebiological agents, the type of polymer, and/or the coating thickness ofone or more biological agents can be used to control the release time,the release rate and/or the dosage amount of one or more biologicalagents; however, other or additional combinations can be used. As such,the biological agent and polymer system combination and location on themedical device can be numerous. As can also be appreciated, one or morebiological agents can be deposited on the top surface of the medicaldevice to provide an initial burst effect of the one or more biologicalagents prior to 1) the control release of the one or more biologicalagents through one or more layers of polymer system that include one ormore non-porous polymers and/or 2) the uncontrolled release of the oneor more biological agents through one or more layers of polymer system.The one or more biological agents and/or polymers can be coated on themedical device by a variety of mechanisms such as, but not limited to,spraying (e.g., atomizing spray techniques, etc.), dip coating, rollcoating, sonication, brushing, plasma deposition, and/or depositing byvapor deposition. The thickness of each polymer layer and/or layer ofbiological agent is generally at least about 0.01 μ and is generallyless than about 150 μ. In one non-limiting embodiment, the thickness ofa polymer layer and/or layer of biological agent is about 0.02-75 μ, andmore particularly about 0.05-50 μ. When the medical device includesand/or is coated with one or more biological agents such that at leastone of the biological agents is at least partially controllably releasedfrom the medical device, the need or use of body-wide therapy forextended periods of time can be reduced or eliminated. In the past, theuse of body-wide therapy was used by the patient long after the patientleft the hospital or other type of medical facility. This body-widetherapy could last days, weeks, months or sometimes over a year aftersurgery. The medical device of the present invention can be applied orinserted into a treatment area and 1) merely requires reduced use and/orextended use of body wide therapy after application or insertion of themedical device or 2) does not require use and/or extended use of bodywide therapy after application or insertion of the medical device. Ascan be appreciated, use and/or extended use of body wide therapy can beused after application or insertion of the medical device at thetreatment area. In one non-limiting example, no body-wide therapy isneeded after the insertion of the medical device into a patient. Inanother non-limiting example, short term use of body-wide therapy isneeded or used after the insertion of the medical device into a patient.Such short term use can be terminated after the release of the patientfrom the hospital or other type of medical facility, or one to two daysor weeks after the release of the patient from the hospital or othertype of medical facility; however, it will be appreciated that othertime periods of body-wide therapy can be used. As a result of the use ofthe medical device of the present invention, the use of body-widetherapy after a medical procedure involving the insertion of a medicaldevice into a treatment area can be significantly reduced or eliminated.

In another and/or alternative non-limiting aspect of the presentinvention, controlled release of one or more biological agents from themedical device, when controlled release is desired, can be accomplishedby using one or more non-porous polymer layers; however, other and/oradditional mechanisms can be used to controllably release the one ormore biological agents. The one or more biological agents are at leastpartially controllably released by molecular diffusion-through the oneor more non-porous polymer layers. When one or more non-porous polymerlayers are used, the one or more polymer layers are typicallybiocompatible polymers; however, this is not required. The one or morenon-porous polymers can be applied to the medical device without the useof chemical, solvents, and/or catalysts; however, this is not required.In one non-limiting example, the non-porous polymer can be at leastpartially applied by, but not limited to, vapor deposition and/or plasmadeposition. The non-porous polymer can be selected so as to polymerizeand cure merely upon condensation from the vapor phase; however, this isnot required. The application of the one or more non-porous polymerlayers can be accomplished without increasing the temperature aboveambient temperature (e.g., 65-90° F.); however, this is not required.The non-porous polymer system can be mixed with one or more biologicalagents prior to being coated on the medical device and/or be coated on amedical device that previously included one or more biological agents;however, this is not required. The use or one or more non-porous polymerlayers allow for accurate controlled release of the biological agentfrom the medical device. The controlled release of one or morebiological agents through the non-porous polymer is at least partiallycontrolled on a molecular level utilizing the motility of diffusion ofthe biological agent through the non-porous polymer. In one non-limitingexample, the one or more non-porous polymer layers can include, but arenot limited to, polyamide, parylene (e.g., parylene C, parylene N)and/or a parylene derivative.

In still another and/or alternative non-limiting aspect of the presentinvention, controlled release of one or more biological agents from themedical device, when controlled release is desired, can be accomplishedby using one or more polymers that form a chemical bond with one or morebiological agents. In one non-limiting example, at least one biologicalagent includes trapidil, trapidil derivative or a salt thereof that iscovalently bonded to at least one polymer such as, but not limited to,an ethylene-acrylic acid copolymer. The ethylene is the hydrophobicgroup and acrylic acid is the hydrophitic group. The mole ratio of theethylene to the acrylic acid in the copolymer can be used to control thehydrophobicity of the copolymer. The degree of hydrophobicity of one ormore polymers can be also be used to control the release rate of one ormore biological agents from the one or more polymers. The amount ofbiological agent that can be loaded with one or more polymers may be afunction of the concentration of anionic groups and/or cationic groupsin the one or more polymer. For biological agents that are anionic, theconcentration of biological agent that can be loaded on the one or morepolymers is generally a function of the concentration of cationic groups(e.g. amine groups and the like) in the one or more polymer and thefraction of these cationic groups that can ionically bind to the anionicform of the one or more biological agents. For biological agents thatare cationic (e.g., trapidil, etc.), the concentration of biologicalagent that can be loaded on the one or more polymers is generally afunction of the concentration of anionic groups (i.e., carboxylategroups, phosphate groups, sulfate groups, and/or other organic anionicgroups) in the one or more polymers, and the fraction of these anionicgroups that can ionically bind to the cationic form of the one or morebiological agents. As such, the concentration of one or more biologicalagent that can be bound to the one or more polymers can be varied bycontrolling the amount of hydrophobic and hydrophilic monomer in the oneor more polymers, by controlling the efficiency of salt formationbetween the biological agent, and/or the anionic/cationic groups in theone or more polymers.

In still another and/or alternative non-limiting aspect of the presentinvention, controlled release of one or more biological agents from themedical device, when controlled release is desired, can be accomplishedby using one or more polymers that include one or more inducedcross-links. These one or more cross-links can be used to at leastpartially control the rate of release of the one or more biologicalagents from the one or more polymers. The cross-linking in the one ormore polymers can be instituted by a number to techniques such as, butnot limited to, using catalysts, using radiation, using heat, and/or thelike. The one or more cross-links formed in the one or more polymers canresult in the one or more biological agents to become partially or fullyentrapped within the cross-linking, and/or form a bond with thecross-linking. As such, the partially or fully biological agent takeslonger to release itself from the cross-linking, thereby delaying therelease rate of the one or more biological agents from the one or morepolymers. Consequently, the amount of biological agent, and/or the rateat which the biological agent is released from the medical device overtime can be at least partially controlled by the amount or degree ofcross-linking in the one or more polymers.

In still a further and/or alternative aspect of the present invention, avariety of polymers can be coated on the medical device and/or be usedto form at least a portion of the medical device. The one or morepolymers can be used on the medical for a variety of reasons such as,but not limit ed to, 1) forming a portion of the medical device, 2)improving a physical property of the medical device (e.g., improvestrength, improve durability, improve biocapatability, reduce friction,etc.), 3) forming a protective coating on one or more surface structureson the medical device, 4) at least partially forming one or more surfacestructures on the medical device, and/or 5) at least partiallycontrolling a release rate of one or more biological agents from themedical device. As can be appreciated, the one or more polymers can haveother or additional uses on the medical device. The one or more polymerscan be porous, non-porous, biostable, biodegradable (i.e., dissolves,degrades, is absorbed, or any combination thereof in the body), and/orbiocompatible. When the medical device is coated with one or morepolymers, the polymer can include 1) one or more coatings of non-porouspolymers; 2) one or more coatings of a combination of one or more porouspolymers and one or more non-porous polymers; 3) one or more coatings ofone or more porous polymers and one or more coatings of one or morenon-porous polymers; 4) one or more coating of porous polymer, or 5) oneor more combinations of options 1, 2, 3 and 4. The thickness of one ormore of the polymer layers can be the same or different. When one ormore layers of polymer are coated onto at least a portion of the medicaldevice, the one or more coatings can be applied by a variety oftechniques such as, but not limited to, vapor deposition and/or plasmadeposition, spraying, dip-coating, roll coating, sonication,atomization, brushing and/or the like; however, other or additionalcoating techniques can be used. The one or more polymers that can becoated on the medical device and/or used to at least partially form themedical device can be polymers that considered to be biodegradable,bioresorbable, or bioerodable; polymers that are considered to bebiostable; and/or polymers that can be made to be biodegradable and/orbioresorbable with modification. Non-limiting examples of polymers thatconsidered to be biodegradable, bioresorbable, or bioerodable include,but are not limited to, aliphatic polyesters; poly(glycolic acid) and/orcopolymers thereof (e.g., poly(glycolide trimethylene carbonate);poly(caprolactone glycolide)); poly(lactic acid) and/or isomers thereof(e.g., poly-L(lactic acid) and/or poly-D Lactic acid) and/or copolymersthereof(e.g. DL-PLA), with and without additives (e.g. calcium phosphateglass), and/or other copolymers (e.g. poly(caprolactone lactide),poly(lactide glycolide), poly(lactic acid ethylene glycol));poly(ethylene glycol); poly(ethylene glycol) diacrylate; poly(lactide);polyalkylene succinate; polybutylene diglycolate; polyhydroxybutyrate(PHB); polyhydroxyvalerate (PHV);polyhydroxybutyrate/polyhydroxyvalerate copolymer (PHB/PHV);poly(hydroxybutyrate-co-valerate); polyhydroxyalkaoates (PHA);polycaprolactone; poly(caprolactone-polyethylene glycol) copolymer;poly(valerolactone); polyanhydrides; poly(orthoesters) and/or blendswith polyanhydrides; poly(anhydride-co-imide); polycarbonates(aliphatic); poly(hydroxyl-esters); polydioxanone; polyanhydrides;polyanhydride esters; polycyanoacrylates; poly(alkyl 2-cyanoacrylates);poly(amino acids); poly(phosphazenes); poly(propylene fumarate);poly(propylene fumarate-co-ethylene glycol); poly(fumarate anhydrides);fibrinogen; fibrin; gelatin; cellulose and/or cellulose derivativesand/or cellulosic polymers (e.g., cellulose acetate, cellulose acetatebutyrate, cellulose butyrate, cellulose ethers, cellulose nitrate,cellulose propionate, cellophane); chitosan and/or chitosan derivatives(e.g., chitosan NOCC, chitosan NOOC-G); alginate; polysaccharides;starch; amylase; collagen; polycarboxylic acids; poly(ethylester-co-carboxylate carbonate) (and/or other tyrosine derivedpolycarbonates); poly(iminocarbonate); poly(BPA-iminocarbonate);poly(trimethylene carbonate); poly(iminocarbonate-amide) copolymersand/or other pseudo-poly(amino acids); poly(ethylene glycol);poly(ethylene oxide); poly(ethylene oxide)/poly(butylene terephthalate)copolymer; poly(epsilon-caprolactone-dimethyltrimethylene carbonate);poly(ester amide); poly(amino acids) and conventional synthetic polymersthereof; poly(alkylene oxalates); poly(alkylcarbonate); poly(adipicanhydride); nylon copolyamides; NO-carboxymethyl chitosan NOCC);carboxymethyl cellulose; copoly(ether-esters) (e.g., PEO/PLA dextrans);polyketals; biodegradable polyethers; biodegradable polyesters;polydihydropyrans; polydepsipeptides; polyarylates (L-tyrosine-derived)and/or free acid polyarylates; polyamides (e.g., Nylon 66,polycaprolactam); poly(propylene fumarate-co-ethylene glycol) (e.g.,fumarate anhydrides); hyaluronates; poly-p-dioxanone; polypeptides andproteins; polyphosphoester; polyphosphoester urethane; polysaccharides;pseudo-poly(amino acids); starch; terpolymer; (copolymers of glycolide,lactide, or dimethyltrimethylene carbonate); rayon; rayon triacetate;latex; and/pr copolymers, blends, and/or composites of above.Non-limiting examples of polymers that considered to be biostableinclude, but are not limited to, parylene; parylene c; parylene f,parylene n; parylene derivatives; maleic anyhydride polymers;phosphorylcholine; poly n-butyl methacrylate (PBMA);polyethylene-co-vinyl acetate (PEVA); PBMA/PEVA blend or copolymer;polytetrafluoroethene (Teflon®) and derivatives; poly-paraphenyleneterephthalamide (Kevlar®); poly(ether ether ketone) (PEEK);poly(styrene-b-isobutylene-b-styrene) (Translute™);tetramethyldisiloxane (side chain or copolymer); polyimidespolysulfides; poly(ethylene terephthalate); poly(methyl methacrylate);poly(ethylene-co-methyl methacrylate); styrene-ethylene/butylene-styreneblock copolymers; ABS; SAN; acrylic polymers and/or copolymers (e.g.,n-butyl-acrylate, n-butyl methacrylate, 2-ethylhexyl acrylate,lauryl-acrylate, 2-hydroxy-propyl acrylate, polyhydroxyethyl,methacrylate/methylmethacrylate copolymers); glycosaminoglycans; alkydresins; elastin; polyether sulfones; epoxy resin; poly(oxymethylene);polyolefins; polymers of silicone; polymers of methane; polyisobutylene;ethylene-alphaolefin copolymers; polyethylene; polyacrylonitrile;fluorosilicones; poly(propylene oxide); polyvinyl aromatics (e.g.polystyrene); poly(vinyl ethers) (e.g. polyvinyl methyl ether);poly(vinyl ketones); poly(vinylidene halides) (e.g. polyvinylidenefluoride, polyvinylidene chloride); poly(vinylpyrolidone);poly(vinylpyrolidone)/vinyl acetate copolymer; polyvinylpridineprolastin or silk-elastin polymers (SELP); silicone; silicone rubber;polyurethanes (polycarbonate polyurethanes, silicone urethane polymer)(e.g., chronoflex varieties, bionate varieties); vinyl halide polymersand/or copolymers (e.g. polyvinyl chloride); polyacrylic acid; ethyleneacrylic acid copolymer; ethylene vinyl acetate copolymer; polyvinylalcohol; poly(hydroxyl alkylmethacrylate); Polyvinyl esters (e.g.polyvinyl acetate); and/or copolymers, blends, and/or composites ofabove. Non-limiting examples of polymers that can made to bebiodegradable and/or bioresorbable with modification include, but arenot limited to, hyaluronic acid (hyanluron); polycarbonates;polyorthocarbonates; copolymers of vinyl monomers; polyacetals;biodegradable polyurethanes; polyacrylamide; polyisocyanates; polyamide;and/or copolymers, blends, and/or composites of above. As can beappreciated, other and/or additional polymers and/or derivatives of oneor more of the above listed polymers can be used. The one or morepolymers can be coated on the medical device by a variety of mechanismssuch as, but not limited to, spraying (e.g., atomizing spray techniques,etc.), dip coating, roll coating, sonication, brushing, plasmadeposition, and/or depositing by vapor deposition. The thickness of eachpolymer layer is generally at least about 0.01 μ and is generally lessthan about 150 μ; however, other thicknesses can be used. In onenon-limiting embodiment, the thickness of a polymer layer and/or layerof biological agent is about 0.02-75 μ, and more particularly about0.05-50 μ. As can be appreciated, other thickness can be used. In onenon-limiting embodiment, the medical device includes and/or is coatedwith parylene, PLGA, POE, PGA, PLLA, PAA, PEG, chitosan and/orderivatives of one or more of these polymers. In another and/oralternative non-limiting embodiment, the medical device includes and/oris coated with a non-porous polymer that includes, but is not limitedto, polyamide, parylene c, parylene n and/or a parylene derivative. Instill another and/or alternative non-limiting embodiment, the medicaldevice includes and/or is coated with poly(ethylene oxide),poly(ethylene glycol), and poly(propylene oxide), polymers of silicone,methane, tetrafluoroethylene (including TEFLON brand polymers),tetramethyldisiloxane, and the like.

In another and/or alternative non-limiting aspect of the presentinvention, the medical device, when including and/or is coated with oneor more biological agents, can include and/or can be coated with one ormore biological agents that are the same or different in differentregions of the medical device and/or have differing amounts and/orconcentrations in differing regions of the medical device. For instance,the medical device can a) be coated -with and/or include one or morebiologicals on at least one portion of the body portion and at leastanother portion of the body portion is not coated with and/or includesbiological agent; b) be coated with and/or include one or morebiologicals on at least one portion of the body portion that isdifferent from one or more biologicals on at least another portion ofthe body portion; c) be coated with and/or include one or morebiologicals at a concentration on at least one portion of the bodyportion that is different from the concentration of one or morebiologicals on at least another portion of the body portion; d) becoated with and/or include one or more biological agents on at least oneportion of the flaring section and at least another portion of theflaring section is not coated with and/or includes biological agent; e)be coated with and/or include one or more biologicals on at least oneportion of the flaring section that is different from one or morebiologicals on at least another portion of the flaring section; f) becoated with and/or include one or more biological agents at aconcentration on at least one portion of the flaring section that isdifferent from the concentration of one or more biologicals on at leastanother portion of the flaring section; g) be coated with and/or includeone or more biologicals on the body portion and the flaring section isnot coated with and/or includes biological agent; h) be coated withand/or include one or more biologicals on the flaring section and thebody portion is not coated with and/or includes biological agent; i) becoated with and/or include one or more biologicals on the body portionthat is different from one or more biologicals on the flaring section;j) be coated with and/or include one or more biological agents at aconcentration on the body portion that is different from theconcentration of one or more biologicals on the flaring section; etc.

In still another and/or alternative non-limiting aspect of the presentinvention, one or more surfaces of the medical device can be treated toachieve the desired coating properties of the one or more biologicalagents and one or more polymers coated on the medical device. Suchsurface treatment techniques include, but are not limited to, cleaning,buffing, smoothing, etching (chemical etching, plasma etching, etc.),etc. When an etching process is used, various gasses can be used forsuch a surface treatment process such as, but not limited to, carbondioxide, nitrogen, oxygen, Freon, helium, hydrogen, etc. The plasmaetching process can be used to clean the surface of the medical device,change the surface properties of the medical device so as to affect theadhesion properties, lubricity properties, etc. of the surface of themedical device. As can be appreciated, other or additional surfacetreatment processes can be used prior to the coating of one or morebiological agents and/or polymers on the surface of the medical device.In one non-limiting manufacturing process, one or more portions of themedical device are cleaned and/or plasma etched; however, this is notrequired. Plasma etching can be used to clean the surface of the medicaldevice, and/or to form one or more non-smooth surfaces on the medicaldevice to facilitate in the adhesion of one or more coatings ofbiological agents and/or one or more coatings of polymer on the medicaldevice. The gas for the plasma etching can include carbon dioxide and/orother gasses. Once one or more surface regions of the medical devicehave been treated, one or more coatings of polymer and/or biologicalagent can be applied to one or more regions of the medical device. Forinstance, 1) one or more layers of porous or non-porous polymer can becoated on an outer and/or inner surface of the medical device, 2) one ormore layers of biological agent can be coated on an outer and/or innersurface of the medical device, or 3) one or more layers of porous ornon-porous polymer that includes one or more biological agents can becoated on an outer and/or inner surface of the medical device. The oneor more layers of biological agent can be applied to the medical deviceby a variety of techniques (e.g., dipping, rolling, brushing, spraying,particle atomization, etc.). One non-limiting coating technique is by anultrasonic mist coating process wherein ultrasonic waves are used tobreak up the droplet of biological agent and form a mist of very finedroplets. These fine droplets have an average droplet diameter of about0.1-3 microns. The fine droplet mist facilitates in the formation of auniform coating thickness and can increase the coverage area on themedical device.

In still yet another and/or alternative non-limiting aspect of thepresent invention, the body portion and/or the flaring section of themedical device can 1) include the same or different biological agents,2) include the same or different amount of one or more biologicalagents, 3) include the same or different polymer coatings, 4) includethe same or different coating thicknesses of one or more polymercoatings, 5) have one or more of both sections controllably releaseand/or uncontrollably release one or more biological agents, and/or 6)have one or more portions of one section controllably release one ormore biological agents and one or more portions of the other sectionuncontrollably release one or more biological agents. In onenon-limiting example, the body portion and the flaring section of themedical device can both or individually include one or more biologicalagents. In another and/or alternative non-limiting example, one or morebiological agents are be the same or different on the body portionand/or the flaring section of the medical device. In still anotherand/or alternative non-limiting example, the body portion and/or theflaring section of the medical device are designed such that the entireamount of biological agent on the body portion and/or the flaringsection is controllably released. In yet another and/or alternativenon-limiting example, the body portion and/or the flaring section of themedical device are designed such that some of the biological agent onthe body portion and/or the flaring section is controllably released andsome of the biological agent on the body portion and/or the flaringsection medical device is non-controllably released. In yet anotherand/or alternative non-limiting example, the body portion and/or theflaring section of the medical device are designed such that none of thebiological agent on the body portion and/or the flaring section iscontrollably released. In still yet another and/or alternativenon-limiting example, the body portion and/or the flaring section of themedical device are designed such that the body portion and/or theflaring section are designed such that the rate of release of the one ormore biological agents from the body portion and/or the flaring sectionis the same or different.

In yet another and/or alternative non-limiting aspect of the invention,the medical device can include a marker material that facilitatesenabling the medical device to be properly positioned in a bodypassageway. The marker material is typically designed to be visible toelectromagnetic waves (e.g., x-rays, microwaves, visible light, inferredwaves, ultraviolet waves, etc.); sound waves (e.g., ultrasound waves,etc.); magnetic waves (e.g., MRI, etc.); and/or other types ofelectromagnetic waves (e.g., microwaves, visible light, inferred waves,ultraviolet waves, etc.). In one non-limiting embodiment, the markermaterial is visible to x-rays (i.e., radiopaque). The marker materialcan form all or a portion of the medical device and/or be coated on oneor more portions (flaring portion and/or body portion; at ends ofmedical device; at or near transition of body portion and flaringsection; etc.) of the medical device. The location of the markermaterial can be on one or multiple locations on the medical device. Thesize of the one or more regions that include the marker material can bethe same or different. The marker material can be spaced at defineddistances from one another so as to form ruler like markings on themedical device to facilitate in the positioning of the medical device ina body passageway. The marker material can be a rigid or flexiblematerial. The marker material can be a biostable or biodegradablematerial. When the marker material is a rigid material, the markermaterial is typically formed of a metal material (e.g., metal band,metal plating, etc.); however, other or additional materials can beused. The metal which at least partially forms the medical device canfunction as a marker material; however, this is not required. When themarker material is a flexible material, the marker material typically isformed of one or more polymers that are marker materialsin-of-themselves and/or include one or more metal powders and/or metalcompounds. In one non-limiting embodiment, the flexible marker materialincludes one or more metal powders in combinations with parylene, PLGA,POE, PGA, PLLA, PAA, PEG, chitosan and/or derivatives of one or more ofthese polymers. In another and/or alternative non-limiting embodiment,the flexible marker material includes one or more metals and/or metalpowders of aluminum, barium, bismuth, cobalt, copper, chromium, gold,iron, stainless steel, titanium, vanadium, nickel, zirconium, niobium,lead, molybdenum, platinum, yttrium, calcium, rare earth metals,rhenium, zinc, silver, depleted radioactive elements, tantalum and/ortungsten; and/or compounds thereof. The marker material can be coatedwith a polymer protective material; however, this is not required. Whenthe marker material is coated with a polymer protective material, thepolymer coating can be used to 1) at least partially insulate the markermaterial from body fluids, 2) facilitate in retaining the markermaterial on the medical device, 3) at least partially shielding themarker material from damage during a medical procedure and/or 4) providea desired surface profile on the medical device. As can be appreciated,the polymer coating can have other or additional uses. The polymerprotective coating can be a biostable polymer or a biodegradable polymer(e.g., degrades and/or is absorbed). The coating thickness of theprotective coating polymer material, when used, is typically less thanabout 300 microns; however, other thickness can be used. In onenon-limiting embodiment, the protective coating materials includeparylene, PLGA, POE, PGA, PLLA, PAA, PEG, chitosan and/or derivatives ofone or more of these polymers.

In still another and/or alternative aspect of the invention, the medicaldevice can be an expandable device that can be expanded by use ofanother device (e.g., balloon, etc.) and/or is self expanding. Theexpandable medical device can be fabricated from a material that has noor substantially no shape memory characteristics or can be fabricatedfrom a material having shape-memory characteristics.

In a further and/or alternative non-limiting aspect of the presentinvention, the medical device or one or more regions of the medicaldevice can be constructed by use of one or more microelectromechanicalmanufacturing techniques (MEMS (e.g., micro-machining, lasermicro-machining, laser micro-machining, micro-molding, etc.)); however,other or additional manufacturing techniques can be used. The medicaldevice can include one or more surface structures (e.g., pore, channel,pit, rib, slot, notch, bump, teeth, well, hole, groove, etc.). Thesestructures can be at least partially formed by MEMS (e.g.,micro-machining, etc.) technology and/or other types of technology. Themedical device can include one or more micro-structures (e.g.,micro-needle, micro-pore, micro-cylinder, micro-cone, micro-pyramid,micro-tube, micro-parallelopiped, micro-prism, micro-hemisphere, teeth,rib, ridge, ratchet, hinge, zipper, zip-tie like structure, etc.) on thesurface of the medical device. Non-limiting examples of structures thatcan be formed on the medical devices such as stents are illustrated inUnited States Patent Publication Nos. 2004/0093076 and 2004/0093077,which are incorporated herein by reference. Typically, themicro-structures, when formed, extend from or into the outer surface nomore than about 400 microns, and more typically less than about 300microns, and more typically about 15-250 microns; however, other sizescan be used. The micro-structures can be clustered together or disbursedthroughout the surface of the medical device. Similar shaped and/orsized micro-structures and/or surface structures can be used, ordifferent shaped and/or sized micro-structures can be used. When one ormore surface structures and/or micro-structures are designed to extendfrom the surface of the medical device, the one or more surfacestructures and/or micro-structures can be formed in the extendedposition and/or be designed so as to extend from the medical deviceduring and/or after deployment of the medical device in a treatmentarea. The micro-structures and/or surface structures can be designed tocontain and/or be fluidly connected to a passageway, cavity, etc.;however, this is not required. The one or more surface structures and/ormicro-structures can be used to engage and/or penetrate surroundingtissue or organs once the medical device has be position on and/or in apatient; however, this is not required. The one or more surfacestructures and/or micro-structures can be used to facilitate in formingmaintaining a shape of a medical device (i.e., see devices in U.S.Patent Publication Nos. 2004/0093076 and 2004/0093077). The one or moresurface structures and/or micro-structures can be at least partiallyformed by MEMS (e.g., micro-machining, laser micro-machining,micro-molding, etc.) technology; however, this is not required. In onenon-limiting embodiment, the one or more surface structures and/ormicro-structures can be at least partially formed of a biological agentand/or be formed of a polymer. One or more of the surface structuresand/or micro-structures can include one or more internal passagewaysthat can include one or more materials (e.g., biological agent, polymer,etc.); however, this is not required. The one or more surface structuresand/or micro-structures can be formed by a variety of processes (e.g.,machining, chemical modifications, chemical reactions, MEMS (e.g.,micro-machining, etc.), etching, laser cutting, etc.). The one or morecoatings and/or one or more surface structures and/or micro-structuresof the medical device can be used for a variety of purposes such as, butnot limited to, 1) increasing the bonding and/or adhesion of one or morebiological agents, adhesives, marker materials and/or polymers to themedical device, 2) changing the appearance or surface characteristics ofthe medical device, and/or 3) controlling the release rate of one ormore biological agents. The one or more micro-structures and/or surfacestructures can be biostable, biodegradable, bioabsorbable, etc. One ormore regions of the medical device that are at least partially formed bymicroelectromechanical manufacturing techniques can be biostable,biodegradable, bioabsorbable, etc. The medical device or one or moreregions of the medical device can be at least partially covered and/orfilled with a protective material so to at least partially protect oneor more regions of the medical device, and/or one or moremicro-structures and/or surface structures on the medical device fromdamage. One or more regions of the medical device, and/or one or moremicro-structures and/or surface structures on the medical device can bedamaged when the medical device is 1) packaged and/or stored, 2)unpackaged, 3) connected to and/or other secured and/or placed onanother medical device, 4) inserted into a treatment area, 5) handled bya user, and/or 6) form a barrier between one or more micro-structuresand/or surface structures and fluids in the body passageway. As can beappreciated, the medical device can be damaged in other or additionalways. The protective material can be used to protect the medical deviceand one or more micro-structures and/or surface structures from suchdamage. The protective material can include one or more polymerspreviously identified above. The protective material can be 1) biostableand/or biodegradable and/or 2) porous and/or non-porous. In onenon-limiting design, the polymer is at least partially biodegradable soas to at least partially exposed one or more micro-structure and/orsurface structure to the environment after the medical device has beenat least partially inserted into a treatment area. In another and/oradditional non-limiting design, the protective material includes, but isnot limited to, sugar (e.g., glucose, fructose, sucrose, etc.),carbohydrate compound, salt (e.g., NaCl, etc.), parylene, PLGA, POE,PGA, PLLA, PAA, PEG, chitosan and/or derivatives of one or more of thesematerials; however, other and/or additional materials can be used. Instill another and/or additional non-limiting design, the thickness ofthe protective material is generally less than about 300 microns, andtypically less than about 150 microns; however, other thicknesses can beused. The protective material can be coated be one or more mechanismpreviously described herein.

In one non-limiting application, the medical device can be designed tobe positioned within a vascular structure. The medical device caninclude a proximal and distal end, and have a certain diameter at theproximal end, and have a different diameter at the distal end, withmultiple different diameters possible between the two ends. The medicaldevice can have an expanded body portion with substantially the samediameter. The medical device can have an expanded body portion withmultiple different diameters. The medical device can have one end thathas the largest expanded diameter (i.e., the flaring section). Themedical device can be designed to have a flaring section that can beexpanded to a maximum flare angle of greater than 90°, yet enable theflaring section to be expanded in a body passageway such that at leastone portion of the expanded flaring section is expanded to a flare angleof less than 90° and one or more other portions of the flaring sectionare expanded to a flare angle of greater than 90°. In one non-limitingdesign, the flaring section can be designed to enable the flare angle ofthe flaring section to be about 15-160°. The medical device can have thesame or different architectural configurations for the body portion andthe flaring section. The medical device can include a biostable and/orbiodegradable material. The biostable material can be a shape memorymaterial; however, this is not required. The biodegradable material,when used, can be dissolved, absorbed, degraded, or any combinationthereof in the body. Various materials that can be used to form one ormore portions of the medical device such as, but are not limited to, oneor more metals and/or metal alloys (aluminum, barium, bismuth, brass,calcium, carbon, chromium, cobalt, cobalt-chromium alloy, copper,depleted radioactive elements, gold, iron, lead, magnesium,magnesium-zirconium alloy, magnesium-zinc alloy, molybdenum,molybdenum-rhenium alloy, nickel, Nitinol, niobium, platinum, rare earthmetals, rhenium, silver, stainless steel, tantalum, tantalum-tungstenalloy, titanium, tungsten, vanadium, yttrium, zinc, zirconium, etc.),fiber materials (e.g., carbon fiber composites, fiberglass, etc.) and/orpolymers (e.g., cellulose acetate, cellulose nitrate, silicone,polyethylene terephthalate, polyurethane, polyamide, polyester,polyorthoester, polyanhydride, polyether sulfone, polycarbonate,polypropylene, high molecular weight polyethylene,polytetrafluoroethylene, polylactic acid, polyglycolic acid orcopolymers thereof, a polyanhydride, polycaprolactone,polyhydroxy-butyrate valerate or another biodegradable polymer ormixtures or copolymers of these, a protein, an extracellular matrixcomponent, collagen, POE (e.g., Translute™), PEVA, PBMA, PLGA, fibrin,polyethylene tetraphthlate (Dacron), expandable polytetrafluoroethylene(e.g., Gortex, Impra, etc.), polyurethane, etc.). The medical device canbe introduced into the vascular structure in a baseline form that is notits final form. The medical device can be balloon expandable; however,this is not required. The medical device can be self-expanding; however,this is not required. The medical device can be deployed by removing aphysical hindrance to allow the medical device to at least partiallyassume its preformed baseline shape; however, this is not required. Thephysical hindrance can include, but is not limited to, an adhesiveand/or sheath; however, other or additional physical hindrances can beused. The medical device can have on the surface and/or within thematrices of the medical device one or more layers of porous and/ornon-porous polymer material; however, this is not required. The one ormore polymer coatings can include biostable compounds and/orbiodegradable compounds. The non-porous polymer material can allow formolecular diffusion of one or more biological agents through thenon-porous polymer material; however, this is not required. Thenon-porous polymer material can include parylene and/or any derivativethereof; however, this is not required. Non-limiting examples ofparylene include, but are not limited to, parylene C, parylene N orcombinations thereof. The medical device can have on its surface and/orwithin the medical device one or more biological agents; however, thisis not required. The biological agent can include, but is not limitedto, includes trapidil, trapidil derivatives, taxol, taxol derivatives,cytochalasin, cytochalasin derivatives, paclitaxel, paclitaxelderivatives, rapamycin, rapamycin derivatives, 5-Phenylmethimazole,5-Phenylmethimazole derivatives, GM-CSF, GM-CSF derivatives, orcombinations thereof. It will be appreciated that other and/oradditional biological agents can be used. The one or more biologicalagents can be coated on the medical device by a variety of techniques.The one or more biological agents can be at least partially coveredand/or at least partially encapsulated by one or more polymer coatingson the medical device to at least partially control the release of theone or more biological agents from the medical device after the medicaldevice has been inserted into a body passageway; however, this is notrequired. The thickness of the one or more polymer coatings can beselected and/or varied to at least partially control the rate of releaseof the one or more biological agents; however, this is not required. Themedical device can include one or more regions that include poroussections and/or channels that can be used to at least partially containone or more biological agents; however, this is not required. Theseporous sections and/or channels can be at least partially loaded withone or more biological agents and/or adhesive material prior to theapplication of one or more coatings of the polymer material of themedical device; however, this is not required. As can be appreciated,the medical device can be nano/micro structured to at least partiallycreate the one or more porous sections and/or channels in the medicaldevice; however, this is not required. The medical device can be formedby a variety of techniques such as, but not limited to, laser cutting,molding, MEMS (e.g., micro-machining) technology, and/or etching. Themedical device can be at least partially formed of a biodegradablematerial and/or a non-biodegradable material. The medical device can beformed by one or more materials that have been mixed with one or morebiological agents; however, this is not required. When the medicaldevice is at least partially formed of a biodegradable polymer, the rateof release of the one or more biological agents, when one or morebiological agents are used, from the medical device can be at leastpartially controlled by varying the concentrations of the one or morepolymers and one or more biological agents used to form the medicaldevice; however, this is not required.

It is one non-limiting object of the invention to provide for a medicaldevice for the treatment of stenosis at the ostium of tubular organs.

It is another and/or alternative non-limiting object of the invention toprovide for a medical device for the treatment of stenosis at the ostiumof blood vessels.

It is still another and/or alternative non-limiting object of theinvention to provide for a medical device which permits the stent to befirmly positioned at the ostium of tubular organs.

It is yet another and/or alternative non-limiting object of the presentinvention to provide a medical device which comprises a contouredexpandable flange to permit the accurate positioning of the medicaldevice, while at the same time preventing dislodgement of the medicaldevice from the position where it had been placed.

It is still yet another and/or alternative non-limiting object of thepresent invention to provide a medical device which comprises acontoured expandable flange that provides improved coverage of theostium.

It is a further and/or alternative non-limiting object of the presentinvention to provide a medical device which comprises a contouredexpandable flange that crushes outwardly when contacted by an adjacentmedical device.

Another and/or alternative non-limiting object of the present inventionis the provision of a medical device that includes one or more surfacestructures and/or micro-structures.

Yet another and/or alternative non-limiting object of the presentinvention is the provision of a medical device that includes one or moreinternal structures, micro-structures and/or surface structures thatinclude and/or are coated with one or more biological agents and/orpolymers.

Still another and/or alternative non-limiting object of the presentinvention is the provision of a medical device that includes one or moresurface structures, micro-structures and/or internal structures and aprotective coating that at least partially covers and/or protects suchstructures.

Yet another and/or alternative non-limiting object of the presentinvention is the provision of a medical device that includes one or moremarkers.

Still yet another and/or alternative non-limiting object of the presentinvention is the provision of a medical device that includes and/or isused with one or more physical hindrances.

These and other objects and advantages will become apparent from thefollowing description taken together with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Reference may now be made to the drawings, which illustrate anembodiment that the invention may take in physical form and in certainparts and arrangements of parts wherein;

FIG. 1 illustrates a perspective view of one embodiment of the medicaldevice in accordance with the invention showing the flared section atone end of the medical device;

FIG. 2 illustrates a sectional side view of the medical device of FIG.1;

FIG. 3 illustrates and end view of the medical device of FIG. 1;

FIG. 4 illustrates the medical device that is collapsed and constrainedwithin a retractable sheath type delivery device;

FIG. 5 illustrates the medical device and a delivery device positionedat the ostium of a vessel with the sheath about to be retracted;

FIG. 6 illustrates the medical device in the fully extended positionplaced within the vessel and its ostium with the flared section of themedical device positioned against the wall of the originating organ;

FIG. 7 illustrates the medical device and an alternative delivery devicepositioned at the ostium of a vessel;

FIG. 8 illustrates the medical device and a delivery device positionedat the ostium of a vessel with a delivery device in an expanded state;

FIG. 9 illustrates a prior art stent procedure involving the use of twoprior art stents at the ostium of a vessel; and,

FIG. 10 illustrates a novel stent procedure in accordance with thepresent invention involving the use of the medical device of the presentinvention and another standard stent at the bifurcation of a vessel.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawings wherein the showings are for the purposeof illustrating the preferred embodiments only and not for the purposeof limiting the same, FIGS. 1-3 illustrate a medical device in anexpanded state in accordance with the present invention. The medicaldevice 10 includes an expandable body portion 20 and a flaring section30. The body portion 20 has a generally uniform tubular shape along thelongitudinal axis of the medical device; however, it will be appreciatedthat the body portion can have other shapes. The body portion isillustrated in FIG. 1 as having a generally constant diameter in theexpanded state; however, this is not required. Typically, the bodyportion has a generally uniform tubular shape in the unexpanded state;however, this is not required. The flaring section 30 is shown to be inthe expanded state as a diverging tubular shape or frustoconical shape.The transition between the body portion and the flaring section does notinclude any breaks. The structural pattern or configuration on the bodyportion (i.e., diamond shaped pattern) is illustrated as substantiallythe same as the structural pattern or configuration on the flaringsection when both the body portion and flaring section are in theexpanded state; however, this is not required. The diameter of theflaring section increases along the longitudinal length of the medicaldevice. The maximum diameter of the flaring section in the expandedstated is at least about 25% greater than the minimum diameter of thebody portion in the expanded state. The outer wall of the flaringsection in the expanded state has a maximum flare angle relative to thelongitudinal axis of the medical device that is over 90° as illustratedin FIGS. 1 and 2. Typically the flaring section in the expanded statehas a maximum flare angle relative to the longitudinal axis of themedical device that is over 100°. Generally the maximum flare anglerelative to the longitudinal axis of the medical device is less thanabout 160°; however, this is not required. The flare angle of theflaring section in the expanded state is illustrated as nonlinear alongthe longitudinal axis of the medical device. As such, the angle of flareof the flaring section increases from about 0° relative to alongitudinal axis of the medical device to a maximum flare angle at anonlinear angular rate. The nonlinear angular rate can result from 1) aplurality of linear rates of flaring over the longitudinal length of theflaring section; 2) a continuously changing angle (e.g., curvilinear)over the longitudinal length of the flaring section as illustrated inFIGS. 1 and 2; or 3) a combination of one or more linear rates offlaring and one or more continuously changing angles over thelongitudinal length of the flaring section.

FIGS. 1 and 2 illustrate that the flaring section and the body portionsubstantially transition into one another without having some type ofspacing (e.g., interspace, etc.) between the body portion and theflaring section. As such, the stent configuration in accordance with thepresent invention is believed to be structurally superior to the stentdisclosed in Mori U.S. Pat. No. 5,466,242. It is also believed that thestent configuration in accordance with the present invention hasimproved expansion properties as compared to the stent disclosed in MoriU.S. Pat. No. 5,466,242.

As illustrated in FIGS. 1 and 2, the flaring section has a smallerlongitudinal length than the body portion. Generally, the body portionconstitutes at least about 60 percent of the longitudinal length of themedical device; however, it can be appreciated that the body portion canconstitute other percentages of the longitudinal length of the medicaldevice. The flaring section and the body portion of the medical deviceare illustrated as formed from a plurality of intersecting wires ormembers. It can be appreciated that the flaring section and-the bodyportion can be formed in a variety of ways, and is not limited to theplurality of intersecting wires or members as illustrated in FIGS. 1-3.As stated above, the structural pattern of the body portion and theflaring section is typically substantially the same; however, this isnot required. As also illustrated in FIGS. 1-3, the flaring sectionmaintains its single structure configuration even after being expanded.At least about 90-95% of the flaring section, in the expanded state,maintains a substantially single and uniform structure.

Prior to and during percutaneous insertion of the medical device into atubular organ, the body portion and the flaring section in theunexpanded state have a generally uniform tubular shape as illustratedin FIG. 4; however, this is not required. Once the medical device hasbeen delivered to the desired location in a tubular organ, the medicaldevice is expanded and/or allowed to expand to its expanded state asillustrated in FIGS. 1-3. The geometric configuration of the walls ofthe medical device can vary for differing specific applicationsdepending upon the requirements for rigidity, radial strength andflexibility. As illustrated in FIG. 3, a central passageway 40 existsalong the longitudinal axis of the medical device. The diameter of thepassageway when the medical device is in an expanded state is sufficientto allow various fluids (e.g., blood, etc.) to pass through the medicaldevice when it has been set in a tubular organ.

Referring now to FIGS. 4-6, the medical device can be collapsed into itsunexpanded state and be at least partially positioned in the vesselostium by a delivery device. The medical device can include one or moremarkers such as radiopaque markers 60 at or near one or both ends of themedical device and/or at or near the location of the demarcation betweenthe body portion and the flaring section so as to allow for better andmore precise positioning of the medical device in a tubular organ. Themedical device can be positioned in the vessel ostium using standardfluoroscopic and angiographic techniques. The medical device can befabricated in different sizes to allow stenting of a wide variety ofvessels or tubular passageways. Applications in which the medical devicecan be used include, but are not limited to, the ostial of the left maincoronary artery, right coronary artery, innominate artery, left commoncarotid artery, subclavian artery, vertebral arteries, renal arteries,hepatic artery, and mesenteric arteries. Venous applications are alsopossible such as, but not limited to, the aorto-ostial anastomoses ofsaphenous vein grafts used in coronary artery bypass grafting.

In one non-limiting technique, the delivery device includes the use of asheath 50 that can be retracted from the medical device to allow themedical device to expand to its expanded state. As shown in FIG. 4,medical device 10 is in the collapsed position or unexpanded state,constrained within the confines of retractable sheath 50. FIG. 5illustrates the medical device in a retractable sheath delivery systeminserted within a vessel 72 at its ostium with the sheath 50 of thedelivery system being partially withdrawn after placement of the medicaldevice 10. In one non-limiting example, vessel 70 can represent the leftmain (LM) coronary artery, vessel 72 can represent the left circumflex(LCx) coronary artery, and vessel 74 can represent the left anteriordescending (LAD) coronary artery. As can be appreciated, the medicaldevice can be inserted into other vessels or body passageways. As shownin FIG. 5, the medical device 10 is guided into the LCx by the deliverydevice. The delivery device is illustrated as including a guide rod 100in combination with a sheath 50; however, it will be appreciated thatother delivery systems could be used. Typically, the pre-expandedflaring section of the medical device sticks slightly out or protrudesin the LM and LAD prior to the expansion of the flaring section. Whenthe flaring section is expanded, at least a portion of the flaringsection expands over 90° to cover the wall about the LCx. As the sheathis removed, the uncovered portion of the medical device expands to itsexpanded state to facilitate in setting the medical device in thevessel. As can be appreciated, an angioplasty balloon, not shown, can beused to expand or facilitate in the expansion of the body portion and/orthe flaring section.

Referring now to FIG. 6, sheath 50 is fully removed from the medicaldevice and the medical device has fully expanded to its expanded state.The medical device is illustrated as firmly secured within vessel 72.The flaring section 30 of the medical device is illustrated as fullycovering the ostium of vessel 72, which in this non-limiting example isthe ostium of the LCx coronary artery. The flaring section is alsoillustrated as covering a portion of the LM coronary artery thatencircles the ostium of the LCx coronary artery. Typically, the size ofthe flaring section is such that at least about 0.5 mm and typically upto about 3-4 mm of the LM coronary artery that encircles the ostium ofthe LCx coronary artery is covered by the flaring section of the stent.The flaring section of the stent is illustrated at conforming closelywith the ostium and the region about the ostium. Because the maximumflare angle for the flaring section is greater than 90°, the outer lipof the flaring section can closely conform with the ostium and theregion about the ostium. As illustrated in FIG. 6, flare angle a is lessthan 90° (e.g., 65°) and flare angle β is greater than 90° (e.g., 110°).Although the flaring section can be expanded to greater than 90°, thesurface of LM coronary artery in one region about the ostium preventsfurther expansion of the flaring section in this region, thus aresulting flare angle of less than 90° at angle α is obtained after theflaring section has been fully expanded. In another region about theostium, the surface of LAD coronary artery allows the flaring section toexpand over 90° until the flaring section contacts the surface of theLAD coronary artery, thus a resulting flare angle of greater than 90° atangle β is obtained after the flaring section has been fully expanded.

The design of the flaring section of the medical device of the presentinvention is a significant improvement over prior art stents wherein 1)a significant portion of the ostium was not covered by the expandedprior art stent, 2) only a portion of the ostium was covered by theprior art stent, and/or 3) one or more portions of the stent formed agap between the stent and a portion of the blood vessel. Theselimitations of prior stents are believed to result in an increasedincidence of restenosis. In many prior art stents, more than 30 percentof the ostium would not be covered by use of the expanded prior artstent. In an effort to try and cover more of the ostium when using priorart stents, the proximal portion of the stent would be allowed toprotrude further out into the parent vessel, in this case, the LMcoronary artery. This increased protrusion is unacceptable as it mayhave adverse clinical consequences including, but not limited to, higherrates of subacute stent thrombosis. Increased protrusion into the parentvessel also increased the risk of inhibiting access to other branchvessels, in this case, the LAD coronary artery, for percutaneousintervention.

The flaring section of the medical device of the present invention isbelieved to overcome all these short comings of prior art stent. Theflaring section of the medical device of the present invention isdesigned to cover at least about 85 percent of the ostium and up to 100%of the ostium in an expanded state without protruding too far into theparent vessel. As illustrated in FIG. 6, the flaring portion of themedical device minimizes or reduces the amount of the medical devicethat extends into the parent vessel 70, which is in this non-limitingexample the LM coronary artery. The end portions of the flaring sectionengage or are closely adjacent to the surface of the LM coronary arterythat surrounds the ostium. The flaring section 30 of the medical devicein combination with a reduction in the amount of protrusion of themedical device into the parent vessel results in enough space to allowaccess to vessel 74, which is in this non-limiting example is the LADcoronary artery, for subsequent medical procedures if needed. The amountof protrusion of prior art stents into the parent vessel commonlyresulted in impaired access to vessel 74, which impaired access couldprevent the insertion of a stent into vessel 74 after a stent in vessel72 has been deployed.

Referring now to FIG. 4, the expansion of the medical device can atleast partially result from the inflation of a balloon and/or by use ofshape memory materials to form the medical device. When a balloon 90 isused as illustrated in FIG. 4, the balloon is at least partiallypositioned in the unexpanded medical device. Once the medical device isproperly positioned in a vessel, the balloon is expanded by a tube 100to cause the medical device to at least partially expand to its expandedstate. The balloon can be inflated prior to, during and/or after thesheath 50 has been at least partially removed from the medical device.After the balloon has at least partially expanded the medical device,the balloon is typically at least partially deflated and removed fromthe passageway of the medical device. As can be appreciated, the sheathand balloon delivery systems can be separate delivery systems that areused mutually exclusive on one another. As such the delivery system mayonly involve the use of a balloon or the use of a sheath.

In another embodiment of the invention, an adhesive is used to at leastpartially secure the medical device to the balloon during the insertionof the medical device into a vessel as illustrated in FIGS. 7 and 8. Inthis embodiment, the delivery device includes a balloon 1 10 that is atleast partially connected to the interior surface of the medical device10 by an adhesive 120. As can be appreciated, the delivery device canalso include a sheath that can be retracted from the medical device toallow the medical device to expand to its expanded state as illustratedin FIGS. 5 and 6. As shown in FIG. 7, medical device 10 is in thecollapsed position or unexpanded state, constrained by the at leastpartially deflated balloon and adhesive 120. The collapsed medicaldevice 10 is inserted into a vascular system by the delivery system andplaced within vessel 72 at its ostia. In one non-limiting example,vessel 70 can represent the LM, vessel 72 can represent the LCx, andvessel 74 can represent the LAD. As can be appreciated, the medicaldevice can be inserted into other vessels or body passageways. As shownin FIG. 7, the medical device 10 is guided into the LCx by the deliverydevice. Typically, the flaring section of the medical device sticks outin the LM prior to the expansion of the flaring section. As balloon 1 10is inflated, the medical device expands to its expanded state tofacilitate in setting the medical device in the vessel. The expansion ofthe balloon causes the adhesive between the balloon and the medicaldevice to break down or otherwise release from the balloon and/ormedical device; thereby at least partially releasing the medical devicefrom the balloon. Once the medical device has been expanded, the balloonis at least partially deflated. Due to the break down or otherwiserelease from the balloon and/or medical device of the adhesive duringthe expansion of the medical device, the balloon can be removed from themedical device when the balloon is at least partially deflated withoutcausing the medical device to be dislodged or be repositioned by theremoval of the balloon from the medical device. As can be appreciated,some adhesive may be left on the balloon and/or medical device after theremoval of the balloon. Typically the adhesive is a biocompatiblematerial. The adhesive is typically a biodegradable material; however,this is not required. The adhesive can include one or more biologicalagents that can be used to provide localized dosages of such biologicalagents to the treated area. The one or more biological agents can beused to facilitate in the healing of the treated area, reduce pain inthe treated area, reduce rejection of the medical device in the treatedarea, reduce restenosis and/or subacute thrombosis, reduce infection;and/or the like. The one or more biological agents in the adhesive canbe controllably and/or uncontrollably released from the adhesive. Theadhesive can be sprayed, painted, dipped, etc. on the medical device.One or more surfaces of the medical device can include the adhesive. Theadhesive can be formulated to withstand sterilization of the medicaldevice; however, this is not required.

Referring now to FIG. 8, the medical device has fully expanded to itsexpanded state. The medical device is illustrated as firmly securedwithin vessel 72. The flaring section 30 of the medical device isillustrated as fully covering the ostium of the LCx. The flaring section30 is illustrated as encircling the ostium of the LCx coronary artery.Typically, the size of the flaring section is such that at least about0.5 mm and typically up to about 3-4 mm of the LM coronary artery thatencircles the ostium of the LCx coronary artery is covered by theflaring section of the stent. The flaring section of the stent isillustrated at conforming closely with the ostium and the region aboutthe ostium. Because the maximum flare angle for the flaring section isgreater than 90°, the outer lip of the flaring section can closelyconform with the ostium and the region about the ostium. As illustratedin FIG. 8, flare angle α is less than 90° (e.g., 65°) and flare angle βis greater than 90° (e.g., 110°). Although the flaring section can beexpanded to greater than 90°, the surface of LM coronary artery in oneregion about the ostium prevents further expansion of the flaringsection in this region, thus a resulting flare angle of less than 90° atangle α is obtained after the flaring section has been fully expanded.In another region about the ostium, the surface of LM coronary arteryallows the flaring section to expand over 90° until the flaring sectioncontacts the surface of the LM coronary artery, thus a resulting flareangle of greater than 90° at angle β is obtained after the flaringsection has been fully expanded. As previously stated, this design ofthe flaring section is a significant improvement over prior art stents.

The expansion of the medical device can at least partially result fromthe use of shape memory materials that are used to at least partiallyform the medical device. The use of shape memory materials can eliminatethe use of a sheath and/or a balloon; however, it can be appreciatedthat the balloon and/or sheath can be used with medical devices thatinclude shape memory materials.

The novel design of the medical device has many advantages over priorart stents. As stated above, the flaring section of the medical deviceincreases the coverage of the ostium. The medical device is believed toreduce the incidence of restenosis. The flaring section of the medicaldevice also simplifies the proper positioning of the medical deviceabout the ostium. Prior stent designs required that the stent bepositioned in a particular manner to achieve success of the stentingprocedure. In most blood vessels, branching is not at a 90° angle. Forinstance the LCx may branch from the LM coronary artery at about a40-130° angle, and thus the ostium of the LCx will not be at a rightangle to the LM. To try to partially compensate for this angularorientation, one end of prior art stents was positioned such that theend partially extended or protruded from the ostium into the LM coronaryartery; however, incomplete coverage of the ostium of the LCx stillresulted. Prior art stents that included a uniform flaring section withan exact point on the stent where the uniform flaring began isillustrated in U.S. Pat. No. 5,466,242. This prior art stent had to beexactly positioned at the ostium in such a manner that the exact pointof the start of the uniform flaring section corresponded exactly withthe ostium of the vascular structure. Such precise positioning wasdifficult to achieve angiographically. The medical device of the presentinvention requires less exact positioning of the graft as required byprior art stents, while at the same time providing complete coverage ofthe ostium as compared to prior art stents. The non-uniform angularflaring section forms a trumpet-shaped region that more closely conformsto the ostium and region about the ostium. Due to the nature of theoutward flare, the distance the medical device of the present inventionthat protrudes or extends into the parent vessel, such as the LMcoronary artery, is minimized. The reduced amount of protrusion isbelieved to reduce the risk of subacute stent thrombosis and furtherallow future vascular access into other branch vessels, such as, the LADcoronary artery.

The novel design of the medical device of the present invention alsoreduces or eliminates the problems associated with the crushing of theend of the medical device by another stent. As illustrated in FIG. 9, aprior art stent 200 is positioned in vessel 150. In one non-limitingexample, vessel 150 can represent the LM coronary artery, vessel 160 canrepresent the LCx coronary artery, and vessel 170 can represent the LADcoronary artery. As can be appreciated, the medical device can beinserted into other vessels or body passageways. Stent 200 is insertedinto the LCx coronary artery and expanded by prior art techniques asdescribed above to increase the flow of blood through the LCx coronaryartery. One end 202 of the stent protrudes or sticks out from the ostium152 of the LCx coronary artery into the LM coronary artery as done instandard practice. After stent 200 is positioned and expanded, a secondstent 220 inserted from the LC coronary artery into the LAD to increasethe flow of blood through this artery. If end 202 of stent 200 deployedin the LCx coronary artery protrudes too far into the LM coronaryartery, the end of stent 200 could interfere with the proper deploymentof stent 220 in the LM and LAD coronary arteries.

Assuming that stent 220 could be properly or at least partially deployedin the LM and LAD coronary arteries, the expansion of stent 220 commonlyresulted in the body of stent 220 contacting end 202 of stent 200 and atleast partially crushing end 202. The crushing of end 202 can result inreduced blood flow through the LCx, increase the amount of metal onmetal contact at the ostium of the LCx coronary artery thereby 1)potentially increasing the risk of restenosis, 2) potentially increasingthe risk of subacute thrombosis, and/or 3) potentially blocking futureaccess into the LCx coronary artery via the LM coronary artery, whichaccess may be required in the future to open the LCx downstream from theposition of stent 200.

Referring now to FIG. 10, medical device 10 in accordance with thepresent invention is positioned in vessel 160. In one non-limitingexample, vessel 150 can represent the LM coronary artery, vessel 160 canrepresent the LCx coronary artery, and vessel 170 can represent the LADcoronary artery. As can be appreciated, the medical device can beinserted into other vessels or body passageways. Medical device 10 isinserted into the LCx coronary artery and expanded by one or more of thetechniques described above to increase the flow of blood through the LCxcoronary artery. The flaring section 30 of the medical device fullycovers the ostium 152 of the LCx coronary artery and conforms closely tothe surface of the LM coronary artery about ostium 152. After medicaldevice 10 is positioned and expanded, a second stent 230 is insertedinto the LAD coronary artery from the LM coronary artery to increase theflow of blood through the LAD coronary artery. The expansion of stent230 results in end 232 contacting a portion of flaring section 30 ofmedical device 10 and at least partially crushing flaring section 30.The crushing of flaring section 30 results in a portion of the flaringsection being pushed further into the surface of the LM coronary arteryabout ostium 152. As a result of the outward flare of the medical device10 of the present invention, which in this example has been positionedin the LCx coronary artery, the crushing of a portion of the flaringsection is controlled such that the crushed portion of medical device 10does not invaginate inwards to cover the ostium of the LCx coronaryartery, but instead is crushed outwards against the walls of the LMcoronary artery and the LAD coronary artery. As such, the crushing ofthe flaring section does not adversely affect the blood flow through theLCx coronary artery, retains complete coverage of ostium 152, and doesnot block future access into the LCx coronary artery via the LM coronaryartery. The reduced amount of metal on metal contact resulting from the“controlled crush” of the flaring section of medical device 10 isbelieved to reduce the risk of restenosis and/or subacute thrombosis.This method of crushing of the flaring section of the medical device isa “controlled” crush. As such, the medical device of the presentinvention is particularly useful treating stenosis of the distal LMcoronary artery, and/or the ostial LCX coronary artery, and/or theostial LAD coronary artery; however, it will be appreciated that medicaldevice can be used in other vessels or body passageways.

It will thus be seen that the objects set forth above, among those madeapparent from the preceding description, are efficiently attained, andsince certain changes may be made in the constructions set forth withoutdeparting from the spirit and scope of the invention, it is intendedthat all matter contained in the above description and shown in theaccompanying drawings shall be interpreted as illustrative and not in alimiting sense. The invention has been described with reference topreferred and alternate embodiments. Modifications and alterations willbecome apparent to those skilled in the art upon reading andunderstanding the detailed discussion of the invention provided herein.This invention is intended to include all such modifications andalterations insofar as they come within the scope of the presentinvention. It is also to be understood that the following claims areintended to cover all of the generic and specific features of theinvention herein described and all statements of the scope of theinvention, which, as a matter of language, might be said to falltherebetween.

1. A medical device designed to be positioned within a vascularstructure, said medical device including a body portion and a flaringsection, said body portion having a body diameter, said flaring sectionhaving a flaring diameter, said body diameter and said flaring diameterbeing different when said sections are in an expanded state, saidflaring diameter being at least about 25% greater than a minimum bodydiameter of said body portion in an expanded state, said flaring sectionhas a maximum flare angle in said expanded state that is greater than90° relative to a longitudinal axis of said body portion.
 2. The graftas defined in claim 1, wherein said flaring section and said bodyportion having substantially the same diameter in a non-expanded state.3. The graft as defined in claim 1, wherein said body portion has asubstantially uniform diameter in said expanded state.
 4. The graft asdefined in claim 1, wherein said flaring section has a nonlinear rate offlaring in said expanded state.
 5. The graft as defined in claim 1,wherein said flaring section has a maximum flare angle in said expandedstate that is less than about 160° relative to a longitudinal axis ofsaid body portion.
 6. The graft as defined in claim 1, wherein at leasta portion of said flaring section has a flare angle in said expandedstate of less than 90° relative to a longitudinal axis of said bodyportion and at least a portion of said flaring section has a flare anglein said expanded state of greater than 90° relative to the longitudinalaxis of said body portion.
 7. The graft as defined in claim 1, whereinsaid flaring section, said body section or combinations thereof includea shape memory material.
 8. The graft as defined in claim 1, including adisengagable physical hindrance that at least partially maintains saidbody portion and said flaring section in an unexpanded form.
 9. Thegraft as defined in claim 8, wherein said physical hindrance includes anadhesive, a sheath or combinations thereof.
 10. The graft as defined inclaim 1, wherein said body portion, said flaring section or combinationsthereof includes one or more layers of porous material, non-porousmaterial, or combinations thereof.
 11. The graft as defined in claim 10,wherein said non-porous material includes parylene or any derivativethereof.
 12. The graft as defined in claim 1, wherein said body portion,said flaring section or combinations thereof includes at least onebiological agent.
 13. The graft as defined in claim 11, wherein saidbody portion, said flaring section or combinations thereof includes atleast one biological agent.
 14. The graft as defined in claim 12,wherein said biological agent includes trapidil, trapidil derivatives,5-Phenylmethimazole, 5-Phenylmethimazole derivatives, GM-CSF, GM-CSFderivatives, or combinations thereof.
 15. The graft as defined in claim13, wherein said biological agent includes trapidil, trapidilderivatives, 5-Phenylmethimazole, 5-Phenylmethimazole derivatives,GM-CSF, GM-CSF derivatives, or combinations thereof.
 16. A medicaldevice designed to be positioned within a vascular structure, saidmedical device including a body portion and a flaring section, said bodyportion having a body diameter, said flaring section having a flaringdiameter, said body diameter and said flaring diameter being differentwhen said sections are in an expanded state, said flaring sectionforming a substantially uniform and single structure in said expandedstate, said flaring section and said body portion formed ofsubstantially the same material, said flaring diameter being at leastabout 25% greater than a minimum body diameter said body portion in anexpanded state, said body portion constituting a majority of alongitudinal length of said medical device, said flaring section has amaximum flare angle in said expanded state that is greater than 90° andless than about 160° relative to a longitudinal axis of said bodyportion, said flaring section has a nonlinear rate of flaring in saidexpanded state.
 17. The graft as defined in claim 16, wherein saidmedical device includes a self-expanding body portion, a self-expandingflaring section, or combinations thereof.
 18. The graft as defined inclaim 16, wherein medical device has a generally uniform structuralpattern for said flaring section and said body portion in said expandedstate.
 19. The graft as defined in claim 16, including a disengagablephysical hindrance that at least partially maintains said body portionand said flaring section in an unexpanded form.
 20. The graft as definedin claim 19, wherein said physical hindrance includes an adhesive, asheath or combinations thereof.
 21. The graft as defined in claim 16,wherein said body portion, said flaring section or combinations thereofincludes one or more layers of porous material, non-porous material, orcombinations thereof.
 22. The graft as defined in claim 21, wherein saidnon-porous material includes parylene or any derivative thereof.
 23. Thegraft as defined in claim 16, wherein said body portion, said flaringsection or combinations thereof includes at least one biological agent.24. The graft as defined in claim 22, wherein said body portion, saidflaring section or combinations thereof includes at least one biologicalagent.
 25. The graft as defined in claim 23, wherein said biologicalagent includes trapidil, trapidil derivatives, 5-Phenylmethimazole,5-Phenylmethimazole derivatives, GM-CSF, GM-CSF derivatives, orcombinations thereof.
 26. The graft as defined in claim 24, wherein saidbiological agent includes trapidil, trapidil derivatives,5-Phenylmethimazole, 5-Phenylmethimazole derivatives, GM-CSF, GM-CSFderivatives, or combinations thereof.
 27. A method of stenting theostium of a tubular organ comprising the steps of: a) inserting amedical device partially into said ostium, said medical device includinga body portion and a flaring section, said body portion having a bodydiameter, said flaring section having a flaring diameter, said bodydiameter and said flaring diameter being different when said sectionsare in an expanded state, said flaring diameter being at least about 25%greater than a minimum body diameter of said body portion in an expandedstate, said flaring section having a maximum flare angle in saidexpanded state that can be greater than 90° relative to a longitudinalaxis of said body portion; and, b) expanding said medical device tocause said body portion to expand in at least a portion of said tubularorgan and to cause said flaring section to substantially fully coversaid ostium and to at least partially inhibit vasculature ingrowth inregions covered by said expanded flaring section, said flaring sectionin an expanded position substantially covering at least about 0.5 mm ofa region about said ostium, at least a portion of said flaring sectionhaving a flare angle in said expanded state that is greater than 90°relative to a longitudinal axis of said body portion.
 28. The method asdefined in claim 27, wherein at least a portion of said flaring sectionhaving a flare angle in said expanded state that is less than 90°relative to a longitudinal axis of said body portion
 29. The method asdefined in claim 27, wherein said medical device includes aself-expanding body portion, a self-expanding flaring section, orcombinations thereof.
 30. The method as defined in claim 27, whereinmedical device has a generally uniform structural pattern for saidflaring section and said body portion in said expanded state.
 31. Themethod as defined in claim 27, wherein said flaring section and saidbody portion are formed of the same material.
 32. The method as definedin claim 27, wherein said body portion constitutes a majority of alongitudinal length of said medical device.
 33. The method as defined inclaim 27, wherein said flaring section has a nonlinear rate of flaringin said expanded state.
 34. The method as defined in claim 27, whereinsaid body portion, said flaring section or combinations thereof includesone or more layers of porous material, non-porous material, orcombinations thereof.
 35. The method as defined in claim 34, includingthe step of at least partially controlling molecular diffusion of atleast one biological agent through said layer of non-porous material.36. The method as defined in claim 35, wherein said non-porous materialincludes parylene or any derivative thereof.
 37. The method as definedin claim 27, wherein said body portion, said flaring section orcombinations thereof includes at least one biological agent.
 38. Themethod as defined in claim 37, wherein said biological agent includestrapidil, trapidil derivatives, 5-Phenylmethimazole, 5-Phenylmethimazolederivatives, GM-CSF, GM-CSF derivatives, or combinations thereof. 39.The method as defined in claim 27, including the step of at leastpartially expanding said medical device by a balloon.
 40. The method asdefined in claim 27, including the step of at least partially expandingsaid medical device by removing a physical hindrance on said medicaldevice.
 41. The method as defined in claim 40, wherein said physicalhindrance includes an adhesive, a sheath, or combinations thereof. 42.The method as defined in claim 41, including the steps of: insertingsaid medical device by use a sheath type delivery system into the ostiumof a tubular organ; and, retracting the sheath to permit said medicaldevice to at least partially expand to said expanded state.
 43. Themethod as defined in claim 42, wherein a balloon is used to at leastpartially assist in the expansion of said medical device.
 44. The methodas defined in claim 42, including the steps of: maintaining at least aportion of said medical device in an unexpanded state by use of anadhesive during insertion of said medical device in said vascularstructure; inserting said medical device by use of delivery system intothe ostium of a tubular organ; and, inflating a balloon to at leastpartially cause said medical device to expand and to at least partiallybreak adhesion by said adhesive between said balloon and said medicaldevice.
 45. The method as defined in claim 27, including the steps ofinserting a second stent in the tubular organ and closely adjacent tosaid medical device after said medical device has been at leastpartially expanded, and expanding said second stent such that a portionof said second stent contacts at least a portion of said flaring sectionof said medical device and causes said portion of said flaring sectionto flare further outwardly.
 46. The method as defined in claim 45,wherein said second stent is deployed extending from the left maincoronary artery into said left anterior descending artery or said leftcircumflex artery.
 47. The method as defined in claim 27, wherein saidmedical device is at least partially formed by MEMS technology.